Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-05-01

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.

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Detailed Description

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Conditions

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Diabetic Foot Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The Study Participant, The Care Provider, and the Investigator are all blinded from the treatments.

Study Groups

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TRIAL INTERVENTION

Trial intervention is wound treatment with Lavior Diabetic Wound Gel.

Group Type ACTIVE_COMPARATOR

Lavior Diabetic Wound Gel

Intervention Type DRUG

Daily application of hydrogel treatment for 60 days.

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.

Group Type ACTIVE_COMPARATOR

Smith & Nephew Solosite Gel Hydrogel Wound Dressing

Intervention Type DRUG

Daily application of hydrogel treatment for 60 days.

Interventions

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Lavior Diabetic Wound Gel

Daily application of hydrogel treatment for 60 days.

Intervention Type DRUG

Smith & Nephew Solosite Gel Hydrogel Wound Dressing

Daily application of hydrogel treatment for 60 days.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No