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

NCT06873867 | Completed Results FDA Device

• 1 other identifier: AIMS/IEC/013/2025
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Full Thickness Skin Defects; Ulcer

Keywords

Full Thickness Skin Defects; Ulcer; Negative Pressure Wound Therapy; High Purity Type 1 Collagen; Helicoll

Outcome Measures

Primary Outcomes (1)

• Percentage Change in Wound Area

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

  7 weeks

Secondary Outcomes (10)

• Histopathological Analysis on Day 5 of Study

  5 days

• Histopathological Analysis on Day 5 of Study - Capillary Density

  5 days

• Time to Achieve Complete Wound Closure

  7 weeks

• Percentage of Participants to Obtain Complete Wound Closure

  7 weeks

• Percentage of Participants Achieving ≥50% Wound Healing

  7 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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; Device: Negative Pressure Wound Therapy

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

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

Interventions

High Purity Type-I Collagen based Skin Substitute DEVICE

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

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

Negative Pressure Wound Therapy DEVICE

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• A subject known to have a life expectancy of \<6 months
• Wounds with active infection / osteomyelitis requiring systemic antibiotics.
• Presence of malignancy in the wound bed.
• Patients with uncontrolled diabetes (HbA1c \> 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.

Sponsors & Collaborators

• Adichunchanagiri Institute of Medical Sciences, B G Nagara: lead

Study Sites (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

Related Publications (5)

• 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.

  PMID: 17425550 BACKGROUND

• 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.

  PMID: 36796046 BACKGROUND

• 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.

  PMID: 33344649 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 39649230 BACKGROUND

MeSH Terms

Conditions

Ulcer

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Limitations and Caveats

The single-center design may limit generalizability. Complete blinding was not feasible due to the nature of interventions, potentially introducing bias, although outcome assessor blinding was maintained. The 7-week study period, while adequate for assessing acute healing outcomes, may not capture long-term benefits or complications such as recurrence rates, functional outcomes

Results Point of Contact

• Title: Dr Naveen N
• Organization: Adichunchanagiri Institute of Medical Sciences

naveen_uno1@yahoo.co.in

+91-9980023372

Study Officials

• Prema Dhanraj, MS, MCh

  Rajarajeshwari Medical College and Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & HoD, Department of Plastic Reconstructive & Aesthetic Surgery

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: March 15, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)