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Completed

NCT Number: NCT05607979

Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

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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Key information

Conditions

Diabetic Foot Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Baefoot Podiatry

Miami, Florida, 33138, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lavior Diabetic Wound Gel

Drug

Daily application of hydrogel treatment for 60 days.

Smith & Nephew Solosite Gel Hydrogel Wound Dressing

Drug

Daily application of hydrogel treatment for 60 days.

Primary outcomes

  1. Primary Endpoint

    Time frame: 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 outcomes

  1. Incidence of wound closures within 60 days

    Time frame: 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

  2. Recurrence

    Time frame: 60 days

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

  3. Change in wound depth over time (cm)

    Time frame: 60 Days

    Change in wound depth (cm) over time will be evaluated by measurement of wound depth (cm) over time

  4. Change in wound surface area over time (cm)

    Time frame: 60 Days

    Change in wound surface area (cm) over time will be evaluated by measurement of wound surface area (cm) over time.

  5. Change of wound size over time (cm)

    Time frame: 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).

  6. Change in Pain Scores over time (60 days)

    Time frame: 60 days

    Change in pain scores will be recorded over time (60 days) through the use of a patient reported 0 -10 scale.

Sponsors and collaborators

Lead sponsor

Lavior Pharma Inc.

Industry

Registry information

Official study title

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

Acronym: RENEW

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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