Clinical trial NCT06873867: Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
Official title: A Comparative Analysis in Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Full Thickness Skin Defects
Ulcer
Keywords: Full Thickness Skin Defects
Ulcer
Negative Pressure Wound Therapy
High Purity Type 1 Collagen
Helicoll
Lead sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage reduction in wound area
timeFrame: 4 weeks
Secondary outcomes:
measure: Infiltration of vascularity in the ulcer bed
timeFrame: 4 weeks
measure: Time to achieve complete wound closure
timeFrame: 4 weeks
measure: Proportion of subjects to obtain complete closure
timeFrame: 4 weeks
measure: Mean time taken for complete epithelialization
timeFrame: 5 weeks
measure: Mean number of repeated application
timeFrame: 4 weeks
measure: Incidence of adverse events
timeFrame: 4 weeks
measure: Change in Pain
timeFrame: 5 weeks
measure: Healed Wound appearance assessment using Manchester Scar Scale
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Mandya
country: India
facility: Adichunchanagiri Institute of Medical Sciences
state: Karnataka
Study officials:
affiliation: Rajarajeshwari Medical College and Hospital
name: Prema Dhanraj, MS, MCh
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.