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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05607979
Other study ID # RENEW-01
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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