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This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. 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 this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using Type-I Collagen-based Skin Substitute in one half of the patients and Dehydrated Human Amnion/Chorion Membrane in the other half.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Other | Arm 1 -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) |
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| SOC and Human Amnion/Chorion Membrane | Other | Arm 2: 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Device | Arm 1 -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 Wound Area Epithelialization From Week 1 Through 4 | Percentage wound area epithelialization from week 1 through 4 measured manually with digital photography. Calculated by using: Percentage Epithelialization=(Epithelialized Area / Total Wound Area)×100 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period | The proportion of subjects that obtain complete closure over the 4-week treatment period | 4 weeks |
| Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure |
| Measure | Description | Time Frame |
|---|---|---|
| Appearance | Visual observation of the newly formed skin for signs of redness, swelling and other abnormalities. Appearance was assessed using visual analog scale, wherein the scale ratings ranged from 0 to 5 where 0 refers to worst appearance and 5 refers to best appearance | The appearance of thewound was assessed only once i.e at the end of 5th week. |
Inclusion Criteria:
Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
At randomization subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement using a ruler to measure wound area.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
The subject must consent to using the prescribed off-loading method for the duration of the study.
The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
The subject must be willing and able to participate in the informed consent process.
Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
Exclusion Criteria:
A subject known to have a life expectancy of <6 months.
If the target ulcer is infected or if there is cellulitis in the surrounding skin.
Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
Topical application of steroids to the ulcer surface within one month of initial screening.
A subject with a previous partial amputation on the affected foot is excluded if the resulting deformity impedes proper offloading of the target ulcer.
A subject with a glycated hemoglobin (HbA1c) greater than or equal to 13% taken at or within 3 months of the initial screening visit.
A subject with a serum creatinine ≥ 3.0mg/dL within 6 months of the initial screening visit.
o A subject with an acute Charcot foot, or an inactive Charcot foot, that impedes proper offloading of the target ulcer.
Women who are pregnant or considering becoming pregnant within the next 6 months.
A subject with end stage renal disease requiring dialysis.
A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
A subject who, in the opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.
A subject treated with hyperbaric oxygen therapy or a Cellular and/or Tissue Product (CTP) in the 30 days prior to the initial screening visit.
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| Name | Affiliation | Role |
|---|---|---|
| Prema Dhanraj, MS, MCh | RajaRajeswari Medical College and Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adichunchanagiri Institute of Medical Sciences | Mandya | Karnataka | 571448 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Dhanraj P, Naveen N, Babu KR, Mahesh MS, Hanumanthaiah KS. Healicoll: An alternate to flap cover for bare bones and tendons. Acta Medica International. 2016 Jan 1;3(1):146-50 | ||
| 36824162 | Background | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | SOC and Type-I Collagen-based Skin Substitute | Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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 | Oct 31, 2024 |
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| SOC and Human Amnion/Chorion Membrane | Other | Arm 2: 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) |
|
Percenatge of participants undergoing repeat applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure. Since the participants who underwent repeat applications in both groups had only one repeat application, instead of the mean number of repeat applications we are indicating the percentage of participants having repeat applications in both the groups. |
| 4 Weeks |
| Structural Stability of the Scar | Structural stability of the healed wound will be assessed by compression testing using a blunt-edged tool. Following assessment by the blunt tool, structural stability was rated on 5 point visual anaog scale, where 1 represents fragile and 5 represents stable wound | The appearance of the woundd was assessed only once i.e. at the end of 5th week. |
| Wound Recurrence | Subject will be observed for any recurrence of the wound after its closure during the 1-week follow-up | During 1-week follow-up |
| 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. |
| FG001 | SOC and Human Amnion/Chorion Membrane | Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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 | SOC and Type-I Collagen-based Skin Substitute | Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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 | SOC and Human Amnion/Chorion Membrane | Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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 |
| |||||||||||||||
| 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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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Smoking | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Doppler Scan Findings | Count of Participants | Participants |
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| Glcosylated Hemoglobin | Mean | Standard Deviation | mmol/mol |
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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 Wound Area Epithelialization From Week 1 Through 4 | Percentage wound area epithelialization from week 1 through 4 measured manually with digital photography. Calculated by using: Percentage Epithelialization=(Epithelialized Area / Total Wound Area)×100 | The number given indicates the average change in wound area in both the groups between baseline and week 4. Since in all the study participants the wound area has decreased, the value in the table indicates average decrease in wound area in both the groups. | Posted | Mean | Standard Deviation | percentage wound area epithelialization | 4 weeks |
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| Secondary | Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period | The proportion of subjects that obtain complete closure over the 4-week treatment period | Posted | Count of Participants | Participants | 4 weeks |
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| Secondary | Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure | Percenatge of participants undergoing repeat applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure. Since the participants who underwent repeat applications in both groups had only one repeat application, instead of the mean number of repeat applications we are indicating the percentage of participants having repeat applications in both the groups. | Posted | Count of Participants | Participants | 4 Weeks |
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| Other Pre-specified | Appearance | Visual observation of the newly formed skin for signs of redness, swelling and other abnormalities. Appearance was assessed using visual analog scale, wherein the scale ratings ranged from 0 to 5 where 0 refers to worst appearance and 5 refers to best appearance | Posted | Mean | Standard Deviation | units on a scale | The appearance of thewound was assessed only once i.e at the end of 5th week. |
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| Other Pre-specified | Structural Stability of the Scar | Structural stability of the healed wound will be assessed by compression testing using a blunt-edged tool. Following assessment by the blunt tool, structural stability was rated on 5 point visual anaog scale, where 1 represents fragile and 5 represents stable wound | Posted | Mean | Standard Deviation | units on a scale | The appearance of the woundd was assessed only once i.e. at the end of 5th week. |
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| Other Pre-specified | Wound Recurrence | Subject will be observed for any recurrence of the wound after its closure during the 1-week follow-up | Posted | Count of Participants | Participants | During 1-week follow-up |
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1 month
All the study participants were considered at risk for adverse events. However, no adverse events were observed in the study.
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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 | SOC and Type-I Collagen-based Skin Substitute | Arm 1 -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) SOC and Type-I Collagen-based Skin Substitute: Arm 1 -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 | 14 | 0 | 14 | 0 | 14 |
| EG001 | SOC and Human Amnion/Chorion Membrane | Arm 2: 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) SOC and Human Amnion/Chorion Membrane: Arm 2: 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 | 14 | 0 | 14 | 0 | 14 |
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Small study group. The findings of the study is applicable only to those individuals without any vascular compromise.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Naveen N | Adichunchanagiri Institute of Medical Sciences, BG Nagara | 9980023372 | +91 | drnaveenn@bgsaims.edu.in |
| Dec 25, 2024 |
| Prot_SAP_002.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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