| Primary | Percentage Change in Wound Area | Percentage change in wound area from week 1 through week 7 measured manually with digital photography | | Posted | | Mean | Standard Deviation | percentage change | | 7 weeks | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
| | | Title | Denominators | Categories |
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| Wound area reduction at 1 week | | | Title | Measurements |
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| - OG00023.73± 11.45
- OG00115.21± 9.32
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| | Wound area reduction at 2 weeks | | |
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| Secondary | Histopathological Analysis on Day 5 of Study | 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 | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 |
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| Secondary | Histopathological Analysis on Day 5 of Study - Capillary Density | 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 | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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| Secondary | Time to Achieve Complete Wound Closure | The time to achieve complete wound closure of the target ulcer by the end of 7 weeks | | Posted | | Mean | Standard Deviation | days | | 7 weeks | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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| Secondary | Percentage of Participants to Obtain Complete Wound Closure | The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up) | | Posted | | Count of Participants | | Participants | | 7 weeks | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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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 | | 7 weeks | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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| Secondary | Mean Number of Application | Mean number of rapplications of the NPWT+HPTC & NPWT alone used to obtain wound closure | | Posted | | Mean | Standard Deviation | number of applications | | 6 weeks | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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| Secondary | Number of Adverse Events | Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues) | | Posted | | Number | | number of adverse events | | 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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| Secondary | Pain Score on Visual Analog Scale | Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0="no pain" to 10="severe pain" | | Posted | | Mean | Standard Deviation | scores on a scale | | 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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| Secondary | Healed Wound Appearance Assessment Using Vancouver Scar Scale | The resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, 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 | | 7 weeks | | | | ID | Title | Description |
|---|
| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | | OG001 | Negative Pressure Wound Therapy | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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| Secondary | Quality of Life Assessment | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Scoring and Ranges:
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EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems).
The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health).
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EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes.
Interpretation: Higher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome. | | Posted | | Mean | Standard Deviation | scores on a scale | | 7 weeks | | | | ID | Title | Description |
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| OG000 | High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. High Purity Type-I Collagen based Skin Substitute: In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed Negative Pressure Wound Therapy: In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed |
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