Diabetic FootNCT02399826
Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers
A study testing Offloading and Dressing Application in people with Diabetic Foot and Foot Ulcer; Diabetic, run by Lower Extremity Institute for Research and Therapy at 3 sites in United States.
Trial summary
This is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period 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, Foot Ulcer; Diabetic
- What is being tested?
- Offloading and Dressing Application
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2015to Jan 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients age 18 or older.
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- Patient's ulcer must be diabetic in origin and larger than 1 cm2.
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks before enrollment randomization, with documented failure of conventional ulcer therapy to heal the wound.
- A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
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- Additional wounds may be present but not within 3 cm of the study wound.
- Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
- Patient's ulcer must exhibit no clinical signs of infection.
- Serum Creatinine less than 3.0mg/dl within last six months.
- HbA1c less than or equal to 12% within last 90 days.
- Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg,
- ABIs with results of ≥0.7 and ≤1.2, OR
- Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
Who cannot join
- Patients presenting with an ulcer probing to tendon, muscle, capsule or bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients whose index diabetic foot ulcers are greater than 25 cm2.
- Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days.
- Patients whose serum creatinine levels are 3.0mg/dl or greater within the last six months.
- Patients with a known history of poor compliance with medical treatments.
- Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
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- Patients who are currently receiving radiation therapy or chemotherapy.
- Patients with known or suspected local skin malignancy to the index diabetic ulcer.
- Patients diagnosed with autoimmune connective tissues diseases.
- Non-revascularizable surgical sites.
- Active infection at site.
- Any pathology that would limit the blood supply and compromise healing.
- Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
- Patients who are pregnant or breast feeding.
- Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
- Patients with known hypersensitivity to components of any treatment used in the trial.
- Wounds greater than one year in duration without intermittent healing.
- Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
- Patients taking Cox-2 inhibitors.
Trial locations and contacts
3 sites in 1 country.
Lawrence Didomenico, DPM contact
Maura Maloney, JD contact
United States3 sites, 3 recruiting
- Recruiting
Lower Extremity Institute of Research and Therapy
Canfield, Ohio, 44406
Lawrence Didomenico, DPM, 330-727-4148
Maura Maloney, JD, 3307160203
- Recruiting
Martinsville Research Institute
Danville, Virginia, 24112
Nathan Young, DPM, 540-676-5886
Kimberly Young, (540) 676-5886
- Recruiting
Shenandoah Lower Extremity Research Institute
Troutville, Virginia, 24019
Jennifer Keller, DPM, 540-529-6155
Hillary Dillow, 540-904-1458
About this study
Official title: A Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers
This is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period
Read the detailed description
This is a prospective, stratified, randomized, comparative, parallel group, Multi-center clinical trial comparing the proportion of ulcers completely healed by use of amniotic membrane graft (Amnioband)versus the standard protocol of wound care in diabetic patients with a diabetic foot ulcer with adequate arterial perfusion, for wound healing to the affected limb. The investigators will compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks. In addition the investigators will compare the proportion of healing at 4 weeks, 12 weeks and, the mean time to healing, and the cost effectiveness of the two protocols of care. Mean time to healing will be measured by wound tracings.
- Conditions
- Diabetic Foot, Foot Ulcer; Diabetic
- Being tested
- Offloading, Dressing Application
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OffloadingDevice
Provision of an offloading cam walker or cast boot, may also convert to "total contact cast" and add felt or foam to supplement
Dressing ApplicationProcedure or surgery
Application of a non adherent dressing, and a multi-layer compression dressing
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Surgical debridement of diabetic foot ulcer, followed by collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice offloading, reassessment weekly at office visit Receives: Device: Offloading |
| Amniotic Membrane / Amnioband | Experimental | Application of Amnioband with dressing application, to be changed weekly following surgical debridement. Patient will practice offloading. If the ulcer is not closed completely Amnioband will be applied weekly at weeks 2-11 Receives: Device: Offloading; Procedure: Dressing Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of ulcers completely healed by amniotic memrane versus standard care
The primary objective of this study is to compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks
Measured: 6 weeks
Secondary outcomes (1)
Proportion of ulcers healed by amniotic membrane versus standard care
The secondary objectives of this study are to compare the proportion of healing at 12 weeks
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 posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2017 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lower Extremity Institute for Research and Therapy
- Sponsor type
- University, hospital or other
- Collaborators
- Musculoskeletal Transplant Foundation
- Responsible party
- Sponsor
- Investigators
- Lawrence Didomenico, DPM, Principal investigator, medical director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399826
- Sponsor's protocol ID
- 001
- Status last verified
- Aug 2016
- First submitted
- 23 Mar 2015
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02399826
- Acronym / sponsor ID
- 001
- Conditions
- Diabetic Foot, Foot Ulcer; Diabetic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lower Extremity Institute for Research and TherapyUniversity, hospital or other
- Collaborators
- Musculoskeletal Transplant Foundation
- Study start
- Mar 2015
- Primary completion
- Jan 2017 (estimated)
- First posted
- 26 Mar 2015 (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 is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period
Detailed description
This is a prospective, stratified, randomized, comparative, parallel group, Multi-center clinical trial comparing the proportion of ulcers completely healed by use of amniotic membrane graft (Amnioband)versus the standard protocol of wound care in diabetic patients with a diabetic foot ulcer with adequate arterial perfusion, for wound healing to the affected limb. The investigators will compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks. In addition the investigators will compare the proportion of healing at 4 weeks, 12 weeks and, the mean time to healing, and the cost effectiveness of the two protocols of care. Mean time to healing will be measured by wound tracings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Device: OffloadingSurgical debridement of diabetic foot ulcer, followed by collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice offloading, reassessment weekly at office visit |
| Amniotic Membrane / Amnioband | Experimental | Device: Offloading, Procedure: Dressing ApplicationApplication of Amnioband with dressing application, to be changed weekly following surgical debridement. Patient will practice offloading. If the ulcer is not closed completely Amnioband will be applied weekly at weeks 2-11 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients age 18 or older.
- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- Patient's ulcer must be diabetic in origin and larger than 1 cm2.
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Ulcer must be present for a minimum of four weeks before enrollment randomization, with documented failure of conventional ulcer therapy to heal the wound.
Key exclusion criteria (19 listed)
- Patients presenting with an ulcer probing to tendon, muscle, capsule or bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients whose index diabetic foot ulcers are greater than 25 cm2.
- Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days.
- Patients whose serum creatinine levels are 3.0mg/dl or greater within the last six months.
- Patients with a known history of poor compliance with medical treatments.
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 |
|---|---|---|
| OffloadingProvision of an offloading cam walker or cast boot, may also convert to "total contact cast" and add felt or foam to supplement | Device | Amniotic Membrane / Amnioband, Standard of Care |
| Dressing ApplicationApplication of a non adherent dressing, and a multi-layer compression dressing | Procedure or surgery | Amniotic Membrane / Amnioband |
Primary outcome
Proportion of ulcers completely healed by amniotic memrane versus standard care
Time frame: 6 weeks
The primary objective of this study is to compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks
1 secondary outcome
Proportion of ulcers healed by amniotic membrane versus standard care
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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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.
Lawrence Didomenico, DPM contact
Maura Maloney, JD contact
Lawrence Didomenico, DPM principal investigator
medical director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Offloading and Dressing Application in people with Diabetic Foot and Foot Ulcer; Diabetic, run by Lower Extremity Institute for Research and Therapy 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 15 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 16 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lawrence Didomenico, DPM (3307274148), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of ulcers completely healed by amniotic memrane versus standard care (time frame: 6 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 16 Aug 2016.