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Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM)
Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. They are prevalent in individuals with limited mobility, such as the elderly and those with spinal cord injuries, particularly in long-term care settings. Effective management of pressure ulcers is crucial to prevent complications and improve patient outcomes, includes pressure relief, wound care, and advanced therapies such as bioengineered skin substitutes. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in promoting the healing of pressure ulcers. While both products are used in wound management, direct comparative studies evaluating their efficacy in treating pressure ulcers are limited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Purity Type-I Collagen-based Skin Substitute | 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 |
|
| Dehydrated Human Amnion/Chorion Membrane | Active Comparator | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Wound Area | Percent Change in Wound Area from week 1 through week 7 measured manually with digital photography | 7 weeks |
| Histopathological Parameters - Vascular Infiltration | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with Hematoxylin and Eosin (H&E) for general morphology. Vascular Infiltration: Assessed by counting new blood vessels per High Power Field (hpf) (0-3 scale) 0: Minimal vascular ingrowth (<5 vessels/hpf)
| Baseline (Day 0), Day 5 |
| Histopathological Parameters - Neo-epithelialization | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology. Neo-epithelialization: Measured as epithelial migration distance from wound edge (0-3 scale) 0: No epithelial migration
| Baseline (Day 0), Day 5 |
| Histopathological Parameters - Fibroblast Activity | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: α-SMA immunohistochemistry for fibroblast activity. Fibroblast Activity: Quantified by counting α-SMA positive fibroblasts per HPF and assessment of fibroblast morphology (0-3 scale) 0: Sparse, inactive fibroblasts
| Baseline (Day 0), Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Wound Closure Rates | Percentage of subjects to obtain complete closure, defined as 100% epithelialization with no drainage, of the target ulcer was determined by the proportion of subjects that obtain complete closure over the 6-week treatment period and additional 1 week follow up | 7 weeks |
| Wound Size Progression Over Time |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Change in quality of life assessed using the Wound-QoL questionnaire measured as 'not at all', 'a little', 'moderately', 'quite a lot' and 'very much' for 17 questions and total number of patients who reported improvement in Quality of Life was measured | 7 weeks |
Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Adichunchanagiri Institute of Medical Sciences | Mandya | Karnataka | 571448 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24050454 | Background | Bergstrom N, Horn SD, Rapp MP, Stern A, Barrett R, Watkiss M. Turning for Ulcer ReductioN: a multisite randomized clinical trial in nursing homes. J Am Geriatr Soc. 2013 Oct;61(10):1705-13. doi: 10.1111/jgs.12440. Epub 2013 Sep 19. | |
| 37711741 | Background | Vecin NM, Kirsner RS. Skin substitutes as treatment for chronic wounds: current and future directions. Front Med (Lausanne). 2023 Aug 29;10:1154567. doi: 10.3389/fmed.2023.1154567. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Purity Type-I Collagen-based Skin Substitute | 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 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
| FG001 | Dehydrated Human Amnion/Chorion Membrane | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Purity Type-I Collagen-based Skin Substitute | 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 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percent Change in Wound Area | Percent Change in Wound Area from week 1 through week 7 measured manually with digital photography | Posted | Mean | Standard Deviation | percentage change | 7 weeks |
|
7 weeks
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 | 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 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Erythema | Immune system disorders | Systematic Assessment |
Single-centre design may limit generalizability to other healthcare settings and populations.
Relatively short follow-up period (7 weeks), while sufficient for assessing acute healing outcomes, may not capture long-term outcomes, recurrence rates or durability of treatment effects.
The Study was not completely blinded due to the nature of the interventions Study included a specific range of wound sizes and may not be generalizable to very large wounds.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Naveen N | Adichunchanagiri Institute of Medical Sciences | +91-9980023372 | naveen_uno1@yahoo.co.in |
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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 | Jul 26, 2025 | Aug 28, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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|
| 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
|
| Histopathological Parameters - Inflammatory Response | 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology Inflammatory Response: Graded semi-quantitatively (0-3 scale) 0: Minimal inflammatory infiltrate
(0-better; 3-worse) | Baseline (Day 0), Day 5 |
| Histopathological Parameters - Capillary Density | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: CD31 immunohistochemistry for capillary density evaluation Capillary Density: Evaluated using CD31 staining, counted as vessels per mm² of tissue More the vessels per square centimeters better | Baseline (Day 0), Day 5 |
| Histopathological Parameters - Collagen Deposition | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Masson's Trichrome for collagen assessment Collagen Deposition: Assessed using Masson's Trichrome staining (0-3 scale) 0: Minimal collagen matrix
(0-worse; 3-better) | Baseline (Day 0), Day 5 |
Mean wound sizes at each time point for both treatment groups assessing change in wound size throughout the study period. Assessed from baseline, through day 5, 14th day, 21 st day, 28th, 35th and 42nd days of HPTC or dHACM application |
| 6 weeks |
| Mean Number of Repeated Application | Mean number of reapplications of the HPTC & dHACM used to obtain wound closure over 6 Weeks | 6 weeks |
| Adverse Events | Adverse events (e.g., infection, allergic reactions) | 6 weeks |
| Patient Treatment Satisfaction | Patient treatment satisfaction will be assessed by using a validated 5-point Likert scale questionnaire administered at 7 weeks post-treatment initiation. The questionnaire evaluated overall treatment satisfaction, comfort during application, perceived effectiveness, and willingness to recommend the treatment to others, measured with score range from 1 to 5, wherein 1="Extremally Unsatisfied" to 5="Extremally Satisfied" | 7 weeks |
| 31067170 | Background | Berhane CC, Brantley K, Williams S, Sutton E, Kappy C. An evaluation of dehydrated human amnion/chorion membrane allografts for pressure ulcer treatment: a case series. J Wound Care. 2019 May 1;28(Sup5):S4-S10. doi: 10.12968/jowc.2019.28.Sup5.S4. |
| 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. |
| BG001 | Dehydrated Human Amnion/Chorion Membrane | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Ulcer duration | Mean | Standard Deviation | Months |
|
| Ulcer size | Mean | Standard Deviation | square centimeters |
|
| Ulcer Location Distribution | Count of Participants | Participants |
|
The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap |
|
|
| Primary | Histopathological Parameters - Vascular Infiltration | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with Hematoxylin and Eosin (H&E) for general morphology. Vascular Infiltration: Assessed by counting new blood vessels per High Power Field (hpf) (0-3 scale) 0: Minimal vascular ingrowth (<5 vessels/hpf)
| Posted | Count of Participants | Participants | Baseline (Day 0), Day 5 |
|
|
|
| Primary | Histopathological Parameters - Neo-epithelialization | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology. Neo-epithelialization: Measured as epithelial migration distance from wound edge (0-3 scale) 0: No epithelial migration
| Posted | Count of Participants | Participants | Baseline (Day 0), Day 5 |
|
|
|
| Primary | Histopathological Parameters - Fibroblast Activity | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: α-SMA immunohistochemistry for fibroblast activity. Fibroblast Activity: Quantified by counting α-SMA positive fibroblasts per HPF and assessment of fibroblast morphology (0-3 scale) 0: Sparse, inactive fibroblasts
| Posted | Count of Participants | Participants | Baseline (Day 0), Day 5 |
|
|
|
| Primary | Histopathological Parameters - Inflammatory Response | 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H&E) for general morphology Inflammatory Response: Graded semi-quantitatively (0-3 scale) 0: Minimal inflammatory infiltrate
(0-better; 3-worse) | Posted | Count of Participants | Participants | Baseline (Day 0), Day 5 |
|
|
|
| Primary | Histopathological Parameters - Capillary Density | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: CD31 immunohistochemistry for capillary density evaluation Capillary Density: Evaluated using CD31 staining, counted as vessels per mm² of tissue More the vessels per square centimeters better | Posted | Mean | Standard Deviation | vessels per square centimeters | Baseline (Day 0), Day 5 |
|
|
|
| Primary | Histopathological Parameters - Collagen Deposition | A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Masson's Trichrome for collagen assessment Collagen Deposition: Assessed using Masson's Trichrome staining (0-3 scale) 0: Minimal collagen matrix
(0-worse; 3-better) | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 0), Day 5 |
|
|
|
| Secondary | Complete Wound Closure Rates | Percentage of subjects to obtain complete closure, defined as 100% epithelialization with no drainage, of the target ulcer was determined by the proportion of subjects that obtain complete closure over the 6-week treatment period and additional 1 week follow up | Posted | Count of Participants | Participants | 7 weeks |
|
|
|
| Secondary | Wound Size Progression Over Time | Mean wound sizes at each time point for both treatment groups assessing change in wound size throughout the study period. Assessed from baseline, through day 5, 14th day, 21 st day, 28th, 35th and 42nd days of HPTC or dHACM application | Posted | Mean | Standard Deviation | sqauare centimeters | 6 weeks |
|
|
|
| Secondary | Mean Number of Repeated Application | Mean number of reapplications of the HPTC & dHACM used to obtain wound closure over 6 Weeks | Posted | Mean | Standard Deviation | mean number of reapplications | 6 weeks |
|
|
|
| Secondary | Adverse Events | Adverse events (e.g., infection, allergic reactions) | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Patient Treatment Satisfaction | Patient treatment satisfaction will be assessed by using a validated 5-point Likert scale questionnaire administered at 7 weeks post-treatment initiation. The questionnaire evaluated overall treatment satisfaction, comfort during application, perceived effectiveness, and willingness to recommend the treatment to others, measured with score range from 1 to 5, wherein 1="Extremally Unsatisfied" to 5="Extremally Satisfied" | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
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| Other Pre-specified | Change in Quality of Life | Change in quality of life assessed using the Wound-QoL questionnaire measured as 'not at all', 'a little', 'moderately', 'quite a lot' and 'very much' for 17 questions and total number of patients who reported improvement in Quality of Life was measured | Posted | Count of Participants | Participants | 7 weeks |
|
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|
| 0 |
| 40 |
| 0 |
| 40 |
| 2 |
| 40 |
| EG001 | Dehydrated Human Amnion/Chorion Membrane | The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing 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, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap | 0 | 40 | 0 | 40 | 6 | 40 |
| Mild Allergic Reaction | Immune system disorders | Systematic Assessment |
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| Lateral malleolus |
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| Heel |
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| Elbow |
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| Grade 2 |
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| Grade 3 |
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| Day 5 Post Application |
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| Grade 2 |
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| Grade 3 |
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| Day 5 of Post Application |
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| Grade 2 |
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| Grade 3 |
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| Day 5 Post Application |
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| Grade 2 |
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| Grade 3 |
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| Day 5 Post Application |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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| Day 35 |
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| Day 42 |
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| Mild Allergic Reaction |
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| Severe adverse events |
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| Worsening |
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