NCT06873867

Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone

Completed NA Results posted Last updated 21 November 2025

What this trial tests

NA trial testing High Purity Type-I Collagen based Skin Substitute in Full Thickness Skin Defects in 104 participants. Completed in 30 September 2025.

Timeline

15 March 2025

Primary endpoint
30 August 2025

30 September 2025

Quick facts

Lead sponsor	Adichunchanagiri Institute of Medical Sciences, B G Nagara
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	104
Start date	15 March 2025
Primary completion	30 August 2025
Estimated completion	30 September 2025
Sites	1 location across India

Drugs / interventions tested

• High Purity Type-I Collagen based Skin Substitute
• Negative Pressure Wound Therapy

Conditions studied

• Full Thickness Skin Defects — all drugs for Full Thickness Skin Defects →
• Ulcer — all drugs for Ulcer →

Sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Who can join

Adults 18 to 80, any sex, with Full Thickness Skin Defects or Ulcer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Change in Wound Area Primary · 7 weeks

Percentage change in wound area from week 1 through week 7 measured manually with digital photography

Wound area reduction at 1 week

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	23.73	± 11.45
Negative Pressure Wound Therapy	15.21	± 9.32

Wound area reduction at 2 weeks

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	34.47	± 13.28
Negative Pressure Wound Therapy	22.52	± 10.85

Wound area reduction at 3 weeks

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	45.17	± 14.67
Negative Pressure Wound Therapy	29.85	± 11.98

Wound area reduction at 4 weeks

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	56.45	± 15.82
Negative Pressure Wound Therapy	36.62	± 12.74

Wound area reduction at 5 weeks

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	67.14	± 16.45
Negative Pressure Wound Therapy	43.97	± 13.28

Wound area reduction at 6 weeks

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	78.33	± 16.98
Negative Pressure Wound Therapy	50.83	± 13.72

Wound area reduction at 7 weeks

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	89.35	± 16.08
Negative Pressure Wound Therapy	57.85	± 12.73

Histopathological Analysis on Day 5 of Study Secondary · 5 days

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

vascular infiltration (0-3 scale)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	2.82	± 0.65
Negative Pressure Wound Therapy	2.10	± 0.58

neo-epithelialization (0-3 scale)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	2.73	± 0.61
Negative Pressure Wound Therapy	1.72	± 0.54

fibroblast activity (0-3 scale)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	2.79	± 0.68
Negative Pressure Wound Therapy	1.63	± 0.52

inflammatory response (0-3 scale)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	1.32	± 0.48
Negative Pressure Wound Therapy	2.35	± 0.63

collagen deposition (0-3 scale)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	2.78	± 0.64
Negative Pressure Wound Therapy	1.43	± 0.49

Histopathological Analysis on Day 5 of Study - Capillary Density Secondary · 5 days

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,

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	48.51	± 8.32
Negative Pressure Wound Therapy	42.97	± 7.85

Time to Achieve Complete Wound Closure Secondary · 7 weeks

The time to achieve complete wound closure of the target ulcer by the end of 7 weeks

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	36.81	± 12.88
Negative Pressure Wound Therapy	43.94	± 16.70

Percentage of Participants to Obtain Complete Wound Closure Secondary · 7 weeks

The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	45
Negative Pressure Wound Therapy	22

Percentage of Participants Achieving ≥50% Wound Healing Secondary · 7 weeks

Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	49
Negative Pressure Wound Therapy	27

Mean Number of Application Secondary · 6 weeks

Mean number of rapplications of the NPWT+HPTC \& NPWT alone used to obtain wound closure

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	1.83	± 0.82
Negative Pressure Wound Therapy	4.3	± 1.72

Number of Adverse Events Secondary · 6 weeks

Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)

Superficial wound infection

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	2
Negative Pressure Wound Therapy	3

Skin irritation around wound

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	1
Negative Pressure Wound Therapy	1

NPWT seal issues

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	1
Negative Pressure Wound Therapy	2

Allergic reaction

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	1
Negative Pressure Wound Therapy	0

Pain during dressing change

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	0
Negative Pressure Wound Therapy	2

Severe infection requiring IV antibiotics

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	0
Negative Pressure Wound Therapy	0

Pain Score on Visual Analog Scale Secondary · 7 weeks

Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0="no pain" to 10="severe pain"

Baseline

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	7.38	± 1.85
Negative Pressure Wound Therapy	7.16	± 1.92

Week 1

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	6.36	± 1.78
Negative Pressure Wound Therapy	6.42	± 1.82

Week 2

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	5.71	± 1.72
Negative Pressure Wound Therapy	5.97	± 1.85

Week 3

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	4.73	± 1.68
Negative Pressure Wound Therapy	5.37	± 1.79

Week 4

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	3.98	± 1.62
Negative Pressure Wound Therapy	4.94	± 1.75

Week 5

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	2.86	± 1.58
Negative Pressure Wound Therapy	4.28	± 1.72

Week 6

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	1.96	± 1.52
Negative Pressure Wound Therapy	3.83	± 1.68

Week 7

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	1.51	± 1.48
Negative Pressure Wound Therapy	3.17	± 1.65

Healed Wound Appearance Assessment Using Vancouver Scar Scale Secondary · 7 weeks

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)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	3.9	± 1.8
Negative Pressure Wound Therapy	9.2	± 2.5

Quality of Life Assessment Secondary · 7 weeks

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: 1. 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 =

EQ-5D Index Score

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	0.91	± 0.102
Negative Pressure Wound Therapy	0.71	± 0.116

EQ-VAS (0-100)

Group	Value	95% CI
High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy	88.2	± 8.3
Negative Pressure Wound Therapy	72.1	± 9.0

Adverse events — posted to ClinicalTrials.gov

Time frame: 6-week treatment period + 1-week follow-up. Total 7 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High Purity Type-I Collagen Based Skin Substitute With Negative Pressure Wound Therapy

Serious: 0/52 (0%)

Deaths: 0/52

Negative Pressure Wound Therapy

Serious: 0/52 (0%)

Deaths: 0/52

Other adverse events (5 terms — click to expand)

Reaction	System	High Purity Type-I Collage…	Negative Pressure Wound Th…
Superficial wound infection	Skin and subcutaneous tissue disorders	—	—
NPWT seal issues	Product Issues	—	—
Pain during dressing change	Skin and subcutaneous tissue disorders	—	—
Skin irritation around wound	Skin and subcutaneous tissue disorders	—	—
Allergic reaction	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT06873867 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Comparative Analysis in the Treatment of Full-Thickness Wounds: Negative-Pressure Wound Therapy (NPWT) Combined With High-Purity Type I Collagen-Based Skin Substitute Versus NPWT Alone.
   Narayan N, Raghupathi D, Ramamurthy V, Chethan S, et al · · 2025 · cited 1× · PMID 41250786 · DOI 10.7759/cureus.96977
2. Immunomodulatory Mechanisms of Chronic Wound Healing: Translational and Clinical Relevance.
   Riaz M, Iqbal MZ, Klar AS, Biedermann T. · · 2025 · cited 1× · PMID 41127507 · DOI 10.1002/mco2.70378
3. Clinical and Histopathological Outcomes of High-Purity Type I Collagen in Chronic Wounds: A Systematic Review of Four Randomized Controlled Trials.
   Narayan N, Nareddula U, Nanjundaiah RK, Manakchand KK. · · 2026 · PMID 41492329 · DOI 10.7759/cureus.100717