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
Trial Information
Current as of April 26, 2025
Not yet recruiting
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.
About Adichunchanagiri Institute Of Medical Sciences, B G Nagara
The Adichunchanagiri Institute of Medical Sciences, located in B.G. Nagara, is a premier healthcare and research institution dedicated to advancing medical knowledge and improving patient care. As a clinical trial sponsor, the institute focuses on conducting rigorous and ethical research across various medical disciplines, aiming to contribute to the development of innovative therapies and treatment protocols. With a commitment to excellence in education, research, and community service, the institute collaborates with leading experts and utilizes state-of-the-art facilities to facilitate impactful clinical trials that adhere to the highest standards of scientific integrity and patient safety.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mandya, Karnataka, India
Patients applied
Trial Officials
Prema Dhanraj, MS, MCh
Study Chair
Rajarajeshwari Medical College and Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported