Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Lavior Pharma Inc.75 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Foot Ulcer

Interventions

Lavior Diabetic Wound GelDRUG

Daily application of hydrogel treatment for 60 days.

Smith & Nephew Solosite Gel Hydrogel Wound DressingDRUG

Daily application of hydrogel treatment for 60 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Baefoot Podiatry

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 60 days

Secondary Outcomes

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

Time frame: 60 days

Recurrence

Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 60 days

Change in Pain Scores over time (60 days)

Data from ClinicalTrials.gov

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