Diabetic Foot UlcersPhase 4NCT02120755
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
A Phase 4 study testing AmnioClear™ Human Allograft Amniotic Membrane in people with Diabetic Foot Ulcers and Wound Care, run by Liventa Bioscience at 1 site in United States.
Trial summary
This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcers, Wound Care
- What is being tested?
- AmnioClear™ Human Allograft Amniotic Membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Oct 2014
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable Type I or II diabetes mellitus
- At least one chronic diabetic ulcer
- Full-thickness ulcer size from 1-8 cm2.
Who cannot join
- Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
- Bleeding disorders
- Ulcer with muscle, tendon, capsule or bone involvement
Trial locations and contacts
1 site in 1 country.
About this study
This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.
The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.
- Conditions
- Diabetic Foot Ulcers, Wound Care
- Being tested
- AmnioClear™ Human Allograft Amniotic Membrane
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmnioClear™ Human Allograft Amniotic MembraneBiological
| Study group | Role | What they receive |
|---|---|---|
| AmnioClear™ | Active comparator | AmnioClear™ Human Allograft Amniotic Membrane Receives: Biological: AmnioClear™ Human Allograft Amniotic Membrane |
| Standard of Care | No intervention | Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Wound Size
Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time.
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 posted23 Apr 2014 (estimated)
- Primary completionOct 2014
Why it stopped: Never Started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liventa Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120755
- Sponsor's protocol ID
- Amn-DFU-01
- Status last verified
- Mar 2016
- First submitted
- 21 Apr 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds
- ClinicalTrials.gov ID
- NCT02120755
- Acronym / sponsor ID
- Amn-DFU-01
- Conditions
- Diabetic Foot Ulcers, Wound Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never Started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liventa BioscienceIndustry (pharma, biotech, devices)
- Primary completion
- Oct 2014 (actual)
- First posted
- 23 Apr 2014 (estimated)
- 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 research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act.
The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AmnioClear™ | Active comparator | Biological: AmnioClear™ Human Allograft Amniotic MembraneAmnioClear™ Human Allograft Amniotic Membrane |
| Standard of Care | No intervention | –Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable Type I or II diabetes mellitus
- At least one chronic diabetic ulcer
- Full-thickness ulcer size from 1-8 cm2.
Key exclusion criteria (3 listed)
- Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents
- Bleeding disorders
- Ulcer with muscle, tendon, capsule or bone involvement
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 |
|---|---|---|
| AmnioClear™ Human Allograft Amniotic Membrane | Biological | AmnioClear™ |
Primary outcome
Reduction in Wound Size
Time frame: 12 Weeks
Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
Related trials for Diabetic Foot Ulcers
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AmnioClear™ Human Allograft Amniotic Membrane in people with Diabetic Foot Ulcers and Wound Care, run by Liventa Bioscience 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 3 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: withdrawn, as of the sponsor's last update on 3 Mar 2016. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Reduction in Wound Size (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 3 Mar 2016.