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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcer; Full Thickness Skin Defects
• Intervention / Treatment: Device: High Purity Type-I Collagen based Skin Substitute; Device: Negative Pressure Wound Therapy

Detailed Description

Full-thickness wounds, extending through the dermis and affecting underlying tissues, present significant clinical challenges due to their complexity and prolonged healing times. Traditional treatments include surgical debridement, dressings, and advanced therapies like Negative Pressure Wound Therapy (NPWT). 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. Studies suggest that HPTC promote cellular proliferation and angiogenesis, essential for tissue regeneration. Given the distinct mechanisms of action of NPWT and HPTC, a comparative evaluation is warranted to determine their relative efficacy in treating full-thickness wounds. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Mandya, Karnataka, India, 571448
      • Adichunchanagiri Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must be at least 18 years of age or older.
2. Presence of a full-thickness wound of at least 4 cm² and no more than 100 cm².
3. Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit.
4. Adequate vascular supply to the affected area
5. 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.
6. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
7. The subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. A subject known to have a life expectancy of <6 months
2. Wounds with active infection / osteomyelitis requiring systemic antibiotics.
3. Presence of malignancy in the wound bed.
4. Patients with uncontrolled diabetes (HbA1c > 9%).
5. Use of immunosuppressive therapy or systemic corticosteroids.
6. Use of other advanced wound care products within the past 30 days
7. Known allergy to fish products or components of HPTC.
8. Pregnant or breastfeeding women.
9. Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
10. A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
11. A subject with autoimmune or connective tissue disorders.
12. A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: 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; Device: 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
Active Comparator: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in Wound Area	Percentage change in wound area from week 1 through week 7 measured manually with digital photography	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Achieve Complete Wound Closure	The time to achieve complete wound closure of the target ulcer by the end of 7 weeks	7 weeks
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	5 days
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,	5 days
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)	7 weeks
Percentage of Participants Achieving ≥50% Wound Healing	Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up	7 weeks
Mean Number of Application	Mean number of rapplications of the NPWT+HPTC & NPWT alone used to obtain wound closure	6 weeks
Number of Adverse Events	Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)	6 weeks
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"	7 weeks
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)	7 weeks
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: 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).; 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.	7 weeks

Collaborators and Investigators

• Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
• Investigators: Study Chair: Prema Dhanraj, MS, MCh, Rajarajeshwari Medical College and Hospital

Publications and helpful links

General Publications

• Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.
• Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020.
• 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.
• Lee SK, An YS, Choy WS. Management of Hardware-Exposed Soft Tissue Defects Using Dermal Substitutes and Negative Pressure Wound Therapy. Ann Plast Surg. 2023 Mar 1;90(3):242-247. doi: 10.1097/SAP.0000000000003440.
• Dhanraj P, Naveen N, Babu KR, Mahesh MS Hanumanthaiah KS. Healicoll: An Alternate to Flap Cover for Bare Bones and Tendons. Acta Medica International, 2016; 3(1): 146-150

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Ulcer; Negative Pressure Wound Therapy; Helicoll; Full Thickness Skin Defects; High Purity Type 1 Collagen
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ulcer; Therapeutics; Surgical Procedures, Operative; Drainage; Wound Closure Techniques; Negative-Pressure Wound Therapy
• Other Study ID Numbers: AIMS/IEC/013/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes