Back to resultsRestoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds (RENEW)
Primary Purpose
Diabetic Foot Ulcer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lavior Diabetic Wound Gel
Smith & Nephew Solosite Gel Hydrogel Wound Dressing
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring diabetes, diabetic foot ulcer, wound, hydrogel, diabetes mellitus
Eligibility Criteria
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
Sites / Locations
- Baefoot PodiatryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TRIAL INTERVENTION
CONTROL THERAPY
Arm Description
Trial intervention is wound treatment with Lavior Diabetic Wound Gel.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Recurrence
Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.
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
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.
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05607979
Brief Title
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
Acronym
RENEW
Official Title
The RENEW Study: (Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds): A Non-Inferiority Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lavior Pharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
diabetes, diabetic foot ulcer, wound, hydrogel, diabetes mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
The Study Participant, The Care Provider, and the Investigator are all blinded from the treatments.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRIAL INTERVENTION
Arm Type
Active Comparator
Arm Description
Trial intervention is wound treatment with Lavior Diabetic Wound Gel.
Arm Title
CONTROL THERAPY
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lavior Diabetic Wound Gel
Intervention Description
Daily application of hydrogel treatment for 60 days.
Intervention Type
Drug
Intervention Name(s)
Smith & Nephew Solosite Gel Hydrogel Wound Dressing
Intervention Description
Daily application of hydrogel treatment for 60 days.
Primary Outcome Measure Information:
Title
Primary Endpoint
Description
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 Outcome Measure Information:
Title
Incidence of wound closures within 60 days
Description
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
Title
Recurrence
Description
Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.
Time Frame
60 days
Title
Change in wound depth over time (cm)
Description
Change in wound depth (cm) over time will be evaluated by measurement of wound depth (cm) over time
Time Frame
60 Days
Title
Change in wound surface area over time (cm)
Description
Change in wound surface area (cm) over time will be evaluated by measurement of wound surface area (cm) over time.
Time Frame
60 Days
Title
Change of wound size over time (cm)
Description
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
Title
Change in Pain Scores over time (60 days)
Description
Change in pain scores will be recorded over time (60 days) through the use of a patient reported 0 -10 scale.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter L Hurwitz
Phone
9177570521
Email
peterh@claritysciences.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Ho Steve Bae, DPM
Organizational Affiliation
Baefoot Podiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baefoot Podiatry
City
Miami
State/Province
Florida
ZIP/Postal Code
33138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Ho Steve Bae, DPM
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
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