Diabetic Foot UlcerPhase 2/3RENEWNCT05607979
Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds
A Phase 2/3 study testing Lavior Diabetic Wound Gel and Smith & Nephew Solosite Gel Hydrogel Wound Dressing in people with Diabetic Foot Ulcer, run by Lavior Pharma Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Lavior Diabetic Wound Gel and Smith & Nephew Solosite Gel Hydrogel Wound Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2022to 1 May 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The RENEW Study: (Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds): A Non-Inferiority Study
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Lavior Diabetic Wound Gel, Smith & Nephew Solosite Gel Hydrogel Wound Dressing
- Keywords
- diabetes, diabetic foot ulcer, wound, hydrogel, diabetes mellitus
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| TRIAL INTERVENTION | Active comparator | Trial intervention is wound treatment with Lavior Diabetic Wound Gel. Receives: Drug: Lavior Diabetic Wound Gel |
| CONTROL THERAPY | Active comparator | 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. Receives: Drug: Smith & Nephew Solosite Gel Hydrogel Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days
Secondary outcomes (6)
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
Measured: 60 days
Recurrence
Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 60 days
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start15 Dec 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lavior Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Ho Steve Bae, DPM, Principal investigator, Baefoot Podiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607979
- Sponsor's protocol ID
- RENEW-01
- Acronym
- RENEW
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RENEW Study: (Restoring Tissue and Evaluating Novel Treatments for Efficacy in Wounds): A Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT05607979
- Acronym / sponsor ID
- RENEW / RENEW-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- diabetes, diabetic foot ulcer, wound, hydrogel, diabetes mellitus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lavior Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| TRIAL INTERVENTION | Active comparator | Drug: Lavior Diabetic Wound GelTrial intervention is wound treatment with Lavior Diabetic Wound Gel. |
| CONTROL THERAPY | Active comparator | Drug: Smith & Nephew Solosite Gel Hydrogel Wound DressingControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavior Diabetic Wound GelDaily application of hydrogel treatment for 60 days. | Drug | TRIAL INTERVENTION |
| Smith & Nephew Solosite Gel Hydrogel Wound DressingDaily application of hydrogel treatment for 60 days. | Drug | CONTROL THERAPY |
Primary outcome
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.
6 secondary outcomes
Incidence of wound closures within 60 days
Time frame: 60 days
Recurrence
Time frame: 60 days
Change in wound depth over time (cm)
Time frame: 60 Days
Change in wound surface area over time (cm)
Time frame: 60 Days
Change of wound size over time (cm)
Time frame: 60 days
Change in Pain Scores over time (60 days)
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Ho Steve Bae, DPM principal investigator
Baefoot Podiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lavior Diabetic Wound Gel and Smith & Nephew Solosite Gel Hydrogel Wound Dressing in people with Diabetic Foot Ulcer, run by Lavior Pharma Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.