N/A
N=80
Treatment of Pressure Ulcers Using Biological Skin Substitutes
Pressure Sore
Bottom Line
View on ClinicalTrials.gov: NCT06853210 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Percent Change in Wound Area — -78.5; -65.1 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Type-I Collagen-based Skin Substitute and SOC (Device); Human Amnion/Chorion Membrane and SOC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Wound Area |
-78.5; -65.1 | — |
| PRIMARY Histopathological Parameters - Vascular Infiltration |
11; 17; 15; 14; 8; 6 | — |
| PRIMARY Histopathological Parameters - Neo-epithelialization |
18; 24; 12; 10; 7; 4 | — |
| PRIMARY Histopathological Parameters - Fibroblast Activity |
7; 12; 17; 16; 13; 10 | — |
| PRIMARY Histopathological Parameters - Inflammatory Response |
21; 12; 14; 16; 5; 11 | — |
| PRIMARY Histopathological Parameters - Capillary Density |
47.3; 28.7 | — |
| PRIMARY Histopathological Parameters - Collagen Deposition |
2.63; 1.77 | — |
| SECONDARY Complete Wound Closure Rates |
30; 25 | — |
| SECONDARY Wound Size Progression Over Time |
14.9; 15.0; 13.1; 13.4; 11.1; 11.5 | — |
| SECONDARY Mean Number of Repeated Application |
0.85; 1.15 | — |
| SECONDARY Adverse Events |
38; 34; 2; 4; 0; 2 | — |
| SECONDARY Patient Treatment Satisfaction |
4.33; 3.41 | — |
Summary
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)
Eligibility Criteria
Inclusion Criteria
- Subjects must be at least 18 years of age or older
- Presence of a Stage II or Stage III pressure ulcer, as defined by the National Pressure Ulcer Advisory Panel
- Ulcer size between 5 cm² and 25 cm²
- Ulcer duration of at least 4 weeks prior to enrollment
- 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
- Adequate blood supply to the affected area, confirmed by clinical assessment
Exclusion Criteria
- A subject known to have a life expectancy of 10%)
Data sourced from ClinicalTrials.gov (NCT06853210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.