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

The RENEW Study: (Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds): A Non-Inferiority Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Drug: Lavior Diabetic Wound Gel; Drug: Smith & Nephew Solosite Gel Hydrogel Wound Dressing

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33138
      • Baefoot Podiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TRIAL INTERVENTION; Trial intervention is wound treatment with Lavior Diabetic Wound Gel.	Drug: Lavior Diabetic Wound Gel; Daily application of hydrogel treatment for 60 days.
Active Comparator: CONTROL THERAPY; 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; Daily application of hydrogel treatment for 60 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of wound closures within 60 days	The incidence of wound closure achieved within each treatment arm will be evaluated after a maximum study observation/treatment period of 60 days	60 days
Recurrence	Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.	60 days
Change in wound depth over time (cm)	Change in wound depth (cm) over time will be evaluated by measurement of wound depth (cm) over time	60 Days
Change in wound surface area over time (cm)	Change in wound surface area (cm) over time will be evaluated by measurement of wound surface area (cm) over time.	60 Days
Change of wound size over time (cm)	Change of Necrotic wound bed surface area (cm) will be evaluated by measurement of necrotic area of wound (cm) over time. Photographic details of wound will be captured at each visit with standardized disposable ruler (cm).	60 days
Change in Pain Scores over time (60 days)	Change in pain scores will be recorded over time (60 days) through the use of a patient reported 0 -10 scale.	60 days

Collaborators and Investigators

• Sponsor: Lavior Pharma Inc.
• Investigators: Principal Investigator: Sung-Ho Steve Bae, DPM, Baefoot Podiatry

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: October 29, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: diabetes; hydrogel; diabetes mellitus; diabetic foot ulcer; wound
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: RENEW-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No