Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds

Diabetic Foot Ulcer Clinical Trial

— RENEW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607979
• Other study ID #: RENEW-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 15, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: March 2024
• Source: Lavior Pharma Inc.
• Contact: Peter L Hurwitz
• Phone: 9177570521
• Email: peterh[@]claritysciences.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Drug:
• Lavior Diabetic Wound Gel
Daily application of hydrogel treatment for 60 days.
• Smith & Nephew Solosite Gel Hydrogel Wound Dressing
Daily application of hydrogel treatment for 60 days.

Locations

Country	Name	City	State
United States	Baefoot Podiatry	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lavior Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Recurrence	Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.	60 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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