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

Launched by ADICHUNCHANAGIRI INSTITUTE OF MEDICAL SCIENCES, B G NAGARA · Mar 7, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat full-thickness wounds, which are deep wounds that go through all layers of the skin. The study will compare two approaches: one that uses a method called negative pressure wound therapy (NPWT) alone and another that combines NPWT with a special skin substitute made from high purity type-I collagen. This combination treatment may help wounds heal faster by providing important support to the skin structure.

To be eligible for the trial, participants need to be at least 18 years old and have a wound that is at least 4 cm² in size and has been present for at least 4 weeks. They must also be able to attend regular study visits, usually twice a week or weekly. However, there are some exclusions; for example, people with active infections, certain medical conditions, or those currently taking specific medications cannot join. If you or a family member are interested, this trial may provide a chance to explore a potentially effective treatment for difficult-to-heal wounds.

Gender

ALL

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.