Diabetic FootNCT03708029
Efficacy of Human Placental Graft in Diabetic Foot Ulcers
A study testing Revita Allograft in people with Diabetic Foot, run by StimLabs at 3 sites in United States.
Trial summary
To determine the efficacy of full-thickness placental allograft in chronic wound healing Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Revita Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Nov 2018to 1 Dec 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- 18-80 years old
- Diagnosis of Type 1 or 2 Diabetes Mellitus
- Foot ulcers >1cm2 and <25cm2 for 4 weeks or more prior to enrollment
- Able to give consent to participate
- Compliance with all aspects of protocol and follow-up
Who cannot join
- Male and female patients younger than 18 years old
- Male or female patients older than 80 years old
- Smoking, and any additional health risk factors contraindicated with Revita use
- Involvement in any other ongoing studies
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Louisiana Foot and Ankle Specialists
Lake Charles, Louisiana, 70605
Gulf Coast Podiatry
Pensacola, Florida, 32503
Crozer/Keystone Health System, Center for Wound Healing
Springfield, Pennsylvania, 19064
About this study
Official title: A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers
To determine the efficacy of full-thickness placental allograft in chronic wound healing
Read the detailed description
To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment
- Conditions
- Diabetic Foot
- Being tested
- Revita Allograft
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revita AllograftOther
Human placental allograft
| Study group | Role | What they receive |
|---|---|---|
| Intervention Treatment | Experimental | Will receive Revita allograft for wound treatment Receives: Other: Revita Allograft |
| Control | No intervention | Will receive current standard of care for wound treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Wound Closure
100% epithelization
Measured: 12 weeks
Secondary outcomes (1)
Percent(%) Healed
Percentage of wound healed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start13 Nov 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- StimLabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Research Manager, Study director, StimLabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708029
- Sponsor's protocol ID
- SLRV-POD-WC-001
- Status last verified
- Jun 2024
- First submitted
- 12 Oct 2018
- Last updated
- 1 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Into the Efficacy of Full-thickness Human Placental Graft (Revita) in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03708029
- Acronym / sponsor ID
- SLRV-POD-WC-001
- Conditions
- Diabetic Foot
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- StimLabsIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 16 Oct 2018 (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.
To determine the efficacy of full-thickness placental allograft in chronic wound healing
Detailed description
To evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to the current standards of wound care treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Treatment | Experimental | Other: Revita AllograftWill receive Revita allograft for wound treatment |
| Control | No intervention | –Will receive current standard of care for wound treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female patients
- 18-80 years old
- Diagnosis of Type 1 or 2 Diabetes Mellitus
- Foot ulcers >1cm2 and <25cm2 for 4 weeks or more prior to enrollment
- Able to give consent to participate
Key exclusion criteria (4 listed)
- Male and female patients younger than 18 years old
- Male or female patients older than 80 years old
- Smoking, and any additional health risk factors contraindicated with Revita use
- Involvement in any other ongoing studies
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 |
|---|---|---|
| Revita AllograftHuman placental allograft | Other | Intervention Treatment |
Primary outcome
Complete Wound Closure
Time frame: 12 weeks
100% epithelization
1 secondary outcome
Percent(%) Healed
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
Related trials for Diabetic Foot
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PAW-Hydrogel for Chronic Wound Healing
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Clinical Research Manager study director
StimLabs
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revita Allograft in people with Diabetic Foot, run by StimLabs at 3 sites 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
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?
Complete Wound Closure (time frame: 12 weeks). 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 1 Jul 2024.