N/A
N=104
Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
Full Thickness Skin Defects · Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT06873867 ↗Enrolled (actual)
104
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Percentage Change in Wound Area — 23.73; 15.21; 34.47; 22.52 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Purity Type-I Collagen based Skin Substitute (Device); Negative Pressure Wound Therapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Wound Area |
23.73; 15.21; 34.47; 22.52; 45.17; 29.85 | — |
| SECONDARY Histopathological Analysis on Day 5 of Study |
2.82; 2.10; 2.73; 1.72; 2.79; 1.63 | — |
| SECONDARY Histopathological Analysis on Day 5 of Study - Capillary Density |
48.51; 42.97 | — |
| SECONDARY Time to Achieve Complete Wound Closure |
36.81; 43.94 | — |
| SECONDARY Percentage of Participants to Obtain Complete Wound Closure |
45; 22 | — |
| SECONDARY Percentage of Participants Achieving ≥50% Wound Healing |
49; 27 | — |
| SECONDARY Mean Number of Application |
1.83; 4.3 | — |
| SECONDARY Number of Adverse Events |
2; 3; 1; 1; 1; 2 | — |
| SECONDARY Pain Score on Visual Analog Scale |
7.38; 7.16; 6.36; 6.42; 5.71; 5.97 | — |
| SECONDARY Healed Wound Appearance Assessment Using Vancouver Scar Scale |
3.9; 9.2 | — |
| SECONDARY Quality of Life Assessment |
0.91; 0.71; 88.2; 72.1 | — |
Summary
Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
Eligibility Criteria
Inclusion Criteria
- Subjects must be at least 18 years of age or older.
- Presence of a full-thickness wound of at least 4 cm² and no more than 100 cm².
- Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit.
- Adequate vascular supply to the affected area
- 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 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.
Exclusion Criteria
- A subject known to have a life expectancy of 9%).
- Use of immunosuppressive therapy or systemic corticosteroids.
- Use of other advanced wound care products within the past 30 days
- Known allergy to fish products or components of HPTC.
- Pregnant or breastfeeding women.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
- A subject with autoimmune or connective tissue disorders.
- A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
Data sourced from ClinicalTrials.gov (NCT06873867). 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.