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| Name | Class |
|---|---|
| Mysore Medical College and Research Institute | OTHER |
| Rajarajeswari Dental College & Hospital | OTHER |
| JSS Medical College Hospital | UNKNOWN |
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This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.
The purpose of the present study is to compare the safety and efficacy of high-purity type-I collagen-based skin substitutes (HPTC), which are free from contaminants such as lipids, elastin, and other immunogenic particles, versus dehydrated human amnion/chorion membrane (dHACM) in the treatment of DFUs. This multicentric randomized, controlled clinical trial seeks to provide valuable insights into the best treatment strategy for enhancing healing outcomes and reducing the challenges posed by chronic DFUs.
Study will be carried out as a multicentric randomized, controlled open-label study to evaluate the safety and effectiveness of High Purity Type-I Collagen-based Skin Substitute (HPTC) compared to Dehydrated Human Amnion/Chorion Membrane (dHACM) for treating diabetic foot ulcers (DFUs). The trial will include patients with DFUs treated by wound care specialists at Adichunchanagiri Institute of Medical Sciences (AIMS), B. G. Nagara, Rajarajeswari Medical College and Hospital (RRMCH), Bangalore, JSS Medical College and Hospital (JSS), Mysore and Mysore Medical College and Research Institute (MMC&RI), Mysore, under the supervision of primary investigator Dr Naveen N. the other principal investigators include Dr Kamal Kumar M, Dr Ravi Shivaiah and Dr Vijay Kumar, respectively. Informed consent will be obtained from all participants prior to any study-related procedures at each of the 3 centres. Each patient will sign an Institutional Ethics Committee / Investigational Review Board (IEC/IRB)-approved consent form, at respective participating centres. IEC/IRB of Adichunchanagiri Institute of Medical Sciences, B. G. Nagara, will be the Designated Ethics Committee (DEC).
The study population will consist of patients seeking treatment for DFUs. Eligible patients will be those willing to participate and comply with scheduled visits on days 7, 10, 14, 17, 21, and 28. The study will include two phases: screening and treatment.
The screening phase aimed to determine patient eligibility for the treatment phase.
Centralized computer-generated block randomization, stratified by centre in a 1:1 ratio will be done. Due to the nature of the interventions, blinding of participants and clinicians is not feasible. However, outcome assessors and data analysts will be blinded to treatment allocation to minimize bias.
The treatment phase of the study will commence with a series of evaluations to ensure patients remained eligible. Participants who will continue to meet the inclusion criteria after the screening phase will be randomly assigned to one of two groups:
Throughout the 4-week treatment phase, patients will be reassessed on days 7, 10, 14, 17, 21, and 28. The SOC dressing applied in both groups consisted of a three-layer system:
If full healing was not achieved, an evaluation will be carried out to check for any signs of clinical infection. If an infection is confirmed, treatment with topical antimicrobials or oral antibiotics will be permitted, though the use of topical antibiotics will be prohibited.
After this infection assessment, the ulcer would be cleaned, photographed, and debrided at the investigator's discretion to ensure a clean and granulating wound base with minimal adherent slough. The Standard of Care (SOC) will be then re-applied, and patients will be instructed to keep the bandage dry. Additionally, they will be advised to contact or return to the study site if the bandage became soiled or removed.
Study Completion Patients will complete the study 4 weeks after their initial treatment visit. However, if a patient's study ulcer healed before the 4-week period, they will be considered to have completed the study at the time of full healing.
Complete healing will be defined as 100% re-epithelialization of the ulcer with no drainage. Throughout the study, patients will retain the right to decline participation or withdraw at any time without prejudice.
In the event of a patient's withdrawal, their last recorded wound measurement will be carried forward to determine the change in wound size and calculate their final outcome.
Study Outcomes
Primary Endpoint:
• The primary outcome of the study will be the proportion of subjects who achieved improvement in wound healing, as observed on days 7, 10, 14, 17, 21, and 28. The wound closure of the target ulcer will be continuously monitored until the end of the 4-week period.
Secondary Endpoints:
Exploratory Endpoint:
• The appearance, structural stability, and fragility of the newly formed skin will be documented at each visit. Any recurrence of the wound will also be monitored.
Statistical Analysis
Data will be analysed on an intention-to-treat basis. Continuous variables will be summarized using means and standard deviations or medians and interquartile ranges, as appropriate. Categorical variables will be presented as frequencies and percentages. Comparative analyses will include:
Multivariable regression models will adjust for potential confounders, such as baseline wound size and patient comorbidities.
Sample Size Calculation Based on previous studies, assuming a 20% difference in the primary outcome between groups, with 60% healing in the dHACM group and 80% in the HPTC group, a sample size of 60 participants per group (total N=60) combined from the 4 centres will provide 80% power to detect this difference at a 5% significance level, accounting for a 10% dropout rate.
Ethical Considerations The study will adhere to the Declaration of Helsinki principles and Good Clinical Practice guidelines. Ethical approval will be obtained from Institutional Ethics Committee of all participating centres. Informed consent will be obtained from all participants before enrolment. Adverse events will be monitored and reported. Participant confidentiality will be maintained, and data will be anonymized. Findings will be submitted to peer-reviewed journals and presented at relevant conferences.
Timeline Recruitment: 1 month Intervention & follow-up assessment: 3 months Data analysis and reporting: 1 month
Potential Implications This study aims to provide robust evidence on the comparative efficacy of HPTC and dHACM in managing DFUs. If HPTC proves superior to dHACM alone, it could establish a standard in treating DFUs, reducing healing time. Positive findings could influence clinical practice guidelines, offering alternative treatment options that may enhance patient outcomes and reduce healthcare costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Purity Type-I Collagen-based Skin Substitute and SOC | Active Comparator | The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
|
| Human Amnion/Chorion Membrane and SOC | Active Comparator | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Purity Type-I Collagen-based Skin Substitute and SOC | Device | The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Wound Area | The primary outcome of the study will be the percentage change in wound area, assessed at 1, 2,3, and 4 weeks, and week 5 reported measured manually with digital photography. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathological Analysis | Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for: vascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better |
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Inclusion Criteria:
Transcutaneous Oxygen Measurement (TCOM) ≥30 mmHg Ankle-Brachial Index (ABI) between 0.7 and 1.3 Peripheral Vascular Resistance (PVR): Biphasic Toe-Brachial Index (TBI) ˃0.6 As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prema Dhanraj, MS, MCh | Rajarajeshwari Medical College and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RajaRajeswari Medical College and Hospital | Bangalore | Karnataka | 560074 | India | ||
| Adichunchanagiri Institute of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39649230 | Background | Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec. | |
| 36824162 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Purity Type-I Collagen-based Skin Substitute and SOC | The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2025 |
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| Dehydrated Human Amnion / Chorion Membrane and SOC | Device | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
|
| 5 days |
| Histopathological Analysis - Capillary Density (Vessels Per mm²) | Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better | 5 days |
| Percentage of Participants to Obtain Complete Wound Closure | The percentage of participants that obtain complete wound closure over the 5 weeks (4 weeks treatment period plus 1 week follow up) | 5 weeks |
| Time to Achieve Complete Wound Closure | Complete wound closure is defined as full epithelialization of the wound with no need for dressings, and sustained closure without signs of infection or breakdown.Time taken for the target ulcer to achieve this will be assessed on days 7, 14, 21, 28 and 35. | 5 weeks |
| Percentage of Participants Achieving ≥50% Wound Healing | Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up | 5 weeks |
| Mean Number of Applications of HPTC / dHACM | The average number of applications of High Purity Type-I Collagen-based Skin Substitute (HPTC) or dehydrated human amniotic/chorionic membrane (dHACM) to achieve wound closure will be documented as part of the study process. | 4 weeks |
| Number of Participants With Adverse Events | To monitor number of participants with adverse events related to the intervention (e.g., infection, allergic reactions) | 4 weeks |
| Patient-Reported Quality of Life Assessed Using Diabetic Foot Ulcer Scale - Short Form (DFS-SF) | The Diabetic Foot Ulcer Scale - Short Form (DFS-SF) is a validated, disease-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of diabetic foot ulcers on patients' wellbeing evaluating four validated sub-scales: Physical Functioning Daily Activities Emotions Social Functioning Subscale Scoring: Scores range from 0-100 for each sub-scale, with higher scores indicating better quality of life. Data were collected at baseline and at Weeks 2, 4, and 5, and week 5 results reported | 5 weeks |
| Healed Wound Appearance Assessment Using Vancouver Scar Scale | The resultant new skin is assessed and documented at each visit up to 5 weeks and week 5 visit reported using the Vancouver Scar Scale assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar) | 5 weeks |
| Mandya |
| Karnataka |
| 571448 |
| India |
| Mysore Medical College and Research Institute | Mysore | Karnataka | 570001 | India |
| JSS Medical College Hospital | Mysore | Karnataka | 570004 | India |
| Wolfe EM, Mathis SA, de la Olivo Munoz N, Ovadia SA, Panthaki ZJ. Comparison of human amniotic membrane and collagen nerve wraps around sciatic nerve reverse autografts in a rat model. Biomater Biosyst. 2022 Apr 7;6:100048. doi: 10.1016/j.bbiosy.2022.100048. eCollection 2022 Jun. |
| 36104736 | Background | Mohammed YA, Farouk HK, Gbreel MI, Ali AM, Salah AA, Nourelden AZ, Gawad MMA. Human amniotic membrane products for patients with diabetic foot ulcers. do they help? a systematic review and meta-analysis. J Foot Ankle Res. 2022 Sep 14;15(1):71. doi: 10.1186/s13047-022-00575-y. |
| 30019528 | Background | DiDomenico LA, Orgill DP, Galiano RD, Serena TE, Carter MJ, Kaufman JP, Young NJ, Jacobs AM, Zelen CM. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients. Int Wound J. 2018 Dec;15(6):950-957. doi: 10.1111/iwj.12954. Epub 2018 Jul 17. |
| 33543031 | Background | Huang Y, Kyriakides TR. The role of extracellular matrix in the pathophysiology of diabetic wounds. Matrix Biol Plus. 2020 Apr 22;6-7:100037. doi: 10.1016/j.mbplus.2020.100037. eCollection 2020 May. |
| 15644549 | Background | Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA. 2005 Jan 12;293(2):217-28. doi: 10.1001/jama.293.2.217. |
| 40747200 | Background | Narayan N, Shivannaiah C, Gowda S. Evaluating the Efficacy of High-Purity Type I Collagen-Based Skin Substitute Versus Dehydrated Human Amnion/Chorion Membrane in the Treatment of Venous Leg Ulcers: A Randomized Controlled Clinical Trial. Cureus. 2025 Jul 30;17(7):e89031. doi: 10.7759/cureus.89031. eCollection 2025 Jul. |
| 40862036 | Background | Narayan N, Ramegowda YH, Raghupathi DS, Chethan S, Gowda S. Biological Skin Substitutes in Pressure Ulcers: High-Purity Type I Collagen-Based Versus Amnion/Chorion Membrane. Cureus. 2025 Aug 25;17(8):e90956. doi: 10.7759/cureus.90956. eCollection 2025 Aug. |
| FG001 | Human Amnion/Chorion Membrane and SOC | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Purity Type-I Collagen-based Skin Substitute and SOC | The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
| BG001 | Human Amnion/Chorion Membrane and SOC | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI (kg/m²) | Mean | Standard Deviation | kg/m^2 |
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| Diabetes duration (years) | Mean | Standard Deviation | years |
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| HbA1c (as percentage) | Mean | Standard Deviation | percentage of HbA1c |
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| Ulcer duration (weeks) | Mean | Standard Deviation | weeks |
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| Ulcer size (cm²) | Mean | Standard Deviation | square centimeters |
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| Ankle-Brachial Index (ABI) | A normal ABI is between 1.0 and 1.4, while a score below 0.9 can indicate peripheral arterial disease (PAD).
How to calculate - The blood pressure is measured in an artery in each arm. The blood pressure is measured in an artery in each ankle. The higher systolic blood pressure from the ankle is divided by the higher systolic blood pressure from the arm to get the ABI. | Mean | Standard Deviation | ratio |
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| Previous ulcer history | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Wound Area | The primary outcome of the study will be the percentage change in wound area, assessed at 1, 2,3, and 4 weeks, and week 5 reported measured manually with digital photography. | Posted | Mean | Standard Deviation | percentage change | 5 weeks |
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| Secondary | Histopathological Analysis | Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for: vascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better | Posted | Mean | Standard Deviation | score on a scale | 5 days |
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| Secondary | Histopathological Analysis - Capillary Density (Vessels Per mm²) | Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better | Posted | Mean | Standard Deviation | vessels per mm² | 5 days |
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| Secondary | Percentage of Participants to Obtain Complete Wound Closure | The percentage of participants that obtain complete wound closure over the 5 weeks (4 weeks treatment period plus 1 week follow up) | Posted | Count of Participants | Participants | 5 weeks |
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| Secondary | Time to Achieve Complete Wound Closure | Complete wound closure is defined as full epithelialization of the wound with no need for dressings, and sustained closure without signs of infection or breakdown.Time taken for the target ulcer to achieve this will be assessed on days 7, 14, 21, 28 and 35. | Posted | Mean | Standard Deviation | days | 5 weeks |
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| Secondary | Percentage of Participants Achieving ≥50% Wound Healing | Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up | Posted | Count of Participants | Participants | 5 weeks |
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| Secondary | Mean Number of Applications of HPTC / dHACM | The average number of applications of High Purity Type-I Collagen-based Skin Substitute (HPTC) or dehydrated human amniotic/chorionic membrane (dHACM) to achieve wound closure will be documented as part of the study process. | Posted | Mean | Standard Deviation | number of applications | 4 weeks |
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| Secondary | Number of Participants With Adverse Events | To monitor number of participants with adverse events related to the intervention (e.g., infection, allergic reactions) | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Patient-Reported Quality of Life Assessed Using Diabetic Foot Ulcer Scale - Short Form (DFS-SF) | The Diabetic Foot Ulcer Scale - Short Form (DFS-SF) is a validated, disease-specific health-related quality of life (HRQoL) questionnaire designed to assess the impact of diabetic foot ulcers on patients' wellbeing evaluating four validated sub-scales: Physical Functioning Daily Activities Emotions Social Functioning Subscale Scoring: Scores range from 0-100 for each sub-scale, with higher scores indicating better quality of life. Data were collected at baseline and at Weeks 2, 4, and 5, and week 5 results reported | Posted | Mean | Standard Deviation | Scores on a scale (0-100) | 5 weeks |
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| Secondary | Healed Wound Appearance Assessment Using Vancouver Scar Scale | The resultant new skin is assessed and documented at each visit up to 5 weeks and week 5 visit reported using the Vancouver Scar Scale assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar) | Posted | Mean | Standard Deviation | scores on a scale (0-13) | 5 weeks |
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5 weeks - From first application (Week 0) through end of follow-up (Week 5).
All the study participants were considered at risk for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Purity Type-I Collagen-based Skin Substitute and SOC | The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) High Purity Type-I Collagen-based Skin Substitute and SOC: The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) | 0 | 60 | 0 | 60 | 4 | 60 |
| EG001 | Human Amnion/Chorion Membrane and SOC | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) | 0 | 60 | 0 | 60 | 11 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Minor allergy | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Mild infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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The study utilized an open-label design, which may introduce performance and detection bias. The follow-up duration of 5 weeks was predetermined and may not allow full evaluation of long-term wound durability or recurrence. The study did not include a pre-planned economic or cost-effectiveness assessment. The study was conducted at selected clinical sites and enrolled a specific diabetic population as per the inclusion/exclusion criteria, which may restrict broader applicability of findings.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Naveen N | Adichunchanagiri Institute of Medical Sciences | +91-9980023372 | naveen_uno1@yahoo.co.in |
| Nov 10, 2025 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
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The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) Dehydrated Human Amnion / Chorion Membrane and SOC: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) |
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