New collagen dressing may speed healing of deep wounds
NCT ID NCT06873867
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding a special collagen-based skin substitute to standard negative pressure wound therapy (NPWT) helps deep wounds heal faster than NPWT alone. It involved 104 adults with full-thickness wounds (at least 4 weeks old) that were not healing well. The main goal was to measure the change in wound size over 7 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
104 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
-
Sep 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Full thickness skin defects are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a muffin help heal stomach ulcers?
- Can a placental patch help heal stubborn diabetic foot ulcers?
- Can a united team heal stubborn ulcers faster?
- Plasma power: new endoscopic treatment could heal Post-Bypass ulcers faster
- Placental grafts show promise for stubborn diabetic foot sores
- Umbilical cord particles show promise for stubborn wounds