Status:
COMPLETED
Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
Lead Sponsor:
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Conditions:
Full Thickness Skin Defects
Ulcer
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ef...
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 treatment...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06873867
Start Date
March 15 2025
End Date
September 30 2025
Last Update
November 21 2025
Active Locations (1)
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1
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India, 571448