Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Drug: Lavior Diabetic Wound Gel; Drug: Smith & Nephew Solosite Gel Hydrogel Wound Dressing

• Registration Number: NCT05607979
• Lead Sponsor: Lavior Pharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-29
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-07
• Study Start: 2022-12-15
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRIAL INTERVENTION	Lavior Diabetic Wound Gel	Trial intervention is wound treatment with Lavior Diabetic Wound Gel.
CONTROL THERAPY	Smith & Nephew Solosite Gel Hydrogel Wound Dressing	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.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	60 days	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.

Secondary Outcome Measures

Name	Time	Method
Change in wound depth over time (cm)	60 Days	Change in wound depth (cm) over time will be evaluated by measurement of wound depth (cm) over time
Change in wound surface area over time (cm)	60 Days	Change in wound surface area (cm) over time will be evaluated by measurement of wound surface area (cm) over time.
Change of wound size over time (cm)	60 days	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).
Change in Pain Scores over time (60 days)	60 days	Change in pain scores will be recorded over time (60 days) through the use of a patient reported 0 -10 scale.
Incidence of wound closures within 60 days	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
Recurrence	60 days	Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.

Trial Locations

Locations (1)

Baefoot Podiatry; 🇺🇸 Miami, Florida, United States