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New collagen dressing may speed healing of deep wounds

NCT ID NCT06873867

Disease control Sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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Conditions

The condition(s) this trial relates to.

ulcer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Full thickness skin defects Ulcer

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.