OCM™ Treatment With Routine Care in Venous Leg Ulcers Compared to Routine Care Treatment Alone.

Conditions

• Venous Leg Ulcer (VLU)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Omeza OCM™ Wound Matrix — DEVICE
  All patients participating in the study will be treated with compression and routine care. The patients in the experimental arm will also be treated with the OCM™ Wound Matrix. Routine wound care will include: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycaemic control * Revascularization if deemed clinically necessary * Continued close observation.
• Routine Care — PROCEDURE
  The routine care intervention will not include treatment with OCM™ and will include: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycaemic control * Revascularization if deemed clinically necessary * Continued close observation.

Study Details

The purpose of the study is to assess the use of OCM™ for the treatment of vascular leg ulcers (VLUs). The study seeks to evaluate the results of treating VLUs with OCM™ plus routine care and compression for complete wound healing; ability of the patient to return to previous function and resume normal activity, and reduction in the size of the wound. The results will be compared to patients who undergo routine care and compression without OCM™.

Key Dates

First listed

Aug 10, 2026

Start date

Aug 31, 2026

Status verified

Aug 2026

Primary completion

Sep 30, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

254 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: OCM™ plus Routine Care
  Patients will undergo weekly treatments with OCM™ plus compression and routine care. Routine care includes: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycemic control * Revascularization if deemed clinically necessary * Continued close observation.
• Active Comparator: Routine Care
  Patients will be treated with compression and routine care only. Routine care includes: * Formal assessment of ulcer and surrounding skin * Managing edema, limb elevation and compression * Managing infection with appropriate antibiotic therapy and * Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae) of necrotic or infected tissue * Appropriate dressing products to avoid any further trauma, facilitate growth of healthy granulation tissue and encourage re-epithelialization * Managing concomitant and inciting medical issues (blood glucose control, tobacco use) * Nutrition and self care * Optimal glycaemic control * Revascularization if deemed clinically necessary * Continued close observation.

Primary Outcome Measure

Change in Ulcer Size [ Time Frame: 16 weeks ]

Central Contacts

• Deborah Klestadt, PhD
  +44 1757 270044
  [email protected]
• Pazely West, BS
  +1 313 473 0569
  [email protected]

Locations (1)

Find similar trials in Lake Success, NY

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