Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Drug: Lavior Diabetic Wound Gel
* Drug: Smith & Nephew Solosite Gel Hydrogel Wound Dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, diabetic foot ulcer, wound, hydrogel, diabetes mellitus