Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds (RENEW)

Lavior Pharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Foot Ulcer

Treatments: Drug: Smith & Nephew Solosite Gel Hydrogel Wound Dressing; Drug: Lavior Diabetic Wound Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05607979

RENEW-01

Details and patient eligibility

About

This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Foot Wound in the setting of Diabetes Mellitus
• Written informed consent
• Minimum wound surface area of 0.7 x 0.7 cm (0.49 square cm)

Exclusion criteria

• Age < 18 years
• Noncompliance with study procedures, visit schedule or follow up Gangrene and/or untreatable Peripheral Arterial Disease
• Malignancy of the wound
• Use of any other hydrogels not being studied in this investigation within 1 month of being enrolled
• Dry, uninfected, stable pressure ulcers of the heel
• Dry, stable eschar in arterial wounds
• Simultaneous participation in competing clinical trials
• Pregnancy or Nursing mothers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

75 participants in 2 patient groups

TRIAL INTERVENTION

Active Comparator group

Description:

Trial intervention is wound treatment with Lavior Diabetic Wound Gel.

Treatment:

Drug: Lavior Diabetic Wound Gel

CONTROL THERAPY

Active Comparator group

Description:

Control therapy is defined as Smith \& Nephew Solosite Gel Hydrogel Wound Dressing, according to actual guidelines or local clinical standards. Standard therapy is defined as the currently accepted and widely used treatment for the respective wound type, based on the results of past research. Therapy options for standard wound care are treatments that experts agree to be appropriate, accepted, and widely used.

Treatment:

Drug: Smith & Nephew Solosite Gel Hydrogel Wound Dressing