Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

NCT05607979 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: RENEW-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Keywords

diabetes; diabetic foot ulcer; wound; hydrogel; diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60. The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60.

  60 days

Secondary Outcomes (6)

• Incidence of wound closures within 60 days

  60 days

• Recurrence

  60 days

• Change in wound depth over time (cm)

  60 Days

• Change in wound surface area over time (cm)

  60 Days

• Change of wound size over time (cm)

  60 days

Study Arms (2)

TRIAL INTERVENTION

ACTIVE COMPARATOR

Trial intervention is wound treatment with Lavior Diabetic Wound Gel.

Drug: Lavior Diabetic Wound Gel

CONTROL THERAPY

ACTIVE COMPARATOR

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.

Drug: Smith & Nephew Solosite Gel Hydrogel Wound Dressing

Interventions

Lavior Diabetic Wound Gel DRUG

Daily application of hydrogel treatment for 60 days.

TRIAL INTERVENTION

Smith & Nephew Solosite Gel Hydrogel Wound Dressing DRUG

Daily application of hydrogel treatment for 60 days.

CONTROL THERAPY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lavior Pharma Inc.: lead

Study Sites (1)

Baefoot Podiatry

Miami, Florida, 33138, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Wounds and Injuries

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sung-Ho Steve Bae, DPM

  Baefoot Podiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The Study Participant, The Care Provider, and the Investigator are all blinded from the treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial

Study Record Dates

• First Submitted: October 29, 2022
• First Posted: November 7, 2022
• Study Start: December 15, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)