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Diabetic Foot UlcerNCT02870816

Prospective, Comparitive, Randomized Study of Allograft Versus Skin Substitute in Non-healing Diabetic Foot Ulcers

A study testing Tissue Engineered Skin Substitute, Offloading and Amnionic Membrane Graft in people with Diabetic Foot Ulcer, run by Professional Education and Research Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs). 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?
Tissue Engineered Skin Substitute, Offloading and Amnionic Membrane Graft
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesUnited States
Study dates
31 Aug 2016to 14 Jun 2018
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female age 18 or older
  • Informed consent must be obtained
  • Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
  • 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 duration, with documented failure of prior treatment to heal the wound.
  • Patient's ulcer must exhibit no clinical signs of infection.
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  • Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle
  • Additional wounds may be present but not within 3cm of the study wound
  • Patient is of legal consenting age.
  • Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
  • Serum Creatinine less then 3.0mg/dl.
  • HbA1c less than 12% taken prior to randomization .
  • Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 90 days:
  • Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
  • 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 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 25cm2.
  • 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 as noted by serum blood testing within the last six months.
  • Patients with a known history of poor compliance with medical treatments.
  • 6 Patients who are presently participating in another clinical trial.
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  • 7. Patients who are currently receiving radiation therapy or chemotherapy.
  • 8. Patients with known or suspected local skin malignancy to the index diabetic ulcer.
  • 9. Patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
  • 10. Patients with uncontrolled autoimmune connective tissues diseases.
  • 11. Non-revascularizable surgical sites.
  • 12. Active infection at site.
  • 13. Any pathology that would limit the blood supply and compromise healing.
  • 14. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
  • 15. Patient who are pregnant or breast feeding .
  • 16. Patient who are taking medications that are considered immune system modulator.
  • 17. Patient taking a cox-2 inhibitor.
  • 18. Patient with wounds healing greater then 20% during the screening period.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Martinsville Research Institute

    Martinsville, Virginia, 24112

  • Shenandoah Lower Extremity Research Institute

    Roanoke, Virginia, 24013

  • Professional Education and Research Institute

    Roanoke, Virginia, 24016

Other trials in United States

About this study

Official title: A Prospective, Randomized, Multi-Center Comparative Study of Amniotic Membrane Wound Graft Application Versus Tissue Engineered Skin Substitute in the Management of Non Healing Diabetic Foot Ulcers

The purpose of this study is to determine whether amnion membrane grafts are more effective than another tissue engineered skin substitute, when used to treat diabetic foot ulcers (DFUs).

Read the detailed description

Diabetes affects at least 9% of the population, or approximately 29 million people in the United States. Lower extremity ulcers are a serious complication for people with diabetes. Diabetic foot-related problems are the most frequent cause of hospitalization within this group and it is estimated that the total cost for treatment ranges from $10,000 to nearly $60,000 depending on ulcer severity and clinical outcomes. While many diabetic foot ulcers are superficial and can heal with conservative treatment, many are more severe and recalcitrant to standard of care (SOC). About a quarter of individuals with diabetes will develop a chronic non-healing ulcer over their lifetime and nearly 60 of every 10,000 individuals with diabetes will undergo a lower extremity amputation. Holzer and associates conducted a retrospective analysis of the costs for lower extremity ulcers in patients with diabetes and concluded that, given the high costs associated with treating these ulcers, the development of better treatment strategies is warranted. One such development in the treatment of chronic wounds is the use of amniotic membrane grafts. These materials have been used successfully for many years in the treatment of orthopedic, plastic/reconstructive, and urological applications. Initial studies have demonstrated the great success of amnionic membrane graft in the healing of chronic diabetic foot ulcers and it is believed that these grafts may be superior to older, more common skin substitutes.

Being tested
Tissue Engineered Skin Substitute, Offloading, Amnionic Membrane Graft
Medical subject headings
Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tissue Engineered Skin SubstituteProcedure or surgery

    Application of skin substitute and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.

  • OffloadingDevice

    Provision of offloading cast walker or similar sponsor-approved device. May convert into "instant total contact cast" and/or add felt/foam to supplement offloading.

  • Amnionic Membrane GraftProcedure or surgery

    Application of amnion membrane graft and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.

Study groups in NCT02870816
Study groupRoleWhat they receive
Tissue engineered skin substituteActive comparatorApplication of tissue engineered skin substitute with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional application of skin substitute will be applied weekly at weeks 2-11.
Receives: Procedure: Tissue Engineered Skin Substitute; Device: Offloading
Amnionic membrane graftExperimentalApplication of amnionic membrane graft with Dressing Application, to be changed weekly following surgical debridement. Patient will practice Offloading. If the ulcer has not closed completely, an additional piece of amnionic membrane graft will be applied weekly at weeks 2-11
Receives: Device: Offloading; Procedure: Amnionic Membrane Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of participants out of 60 with complete healing of their diabetic foot ulcers as measured by complete epithialization of the foot wound comparing the two active treatment groups

    Examine the number of patient that go onto complete healing

    Measured: 6 weeks

Secondary outcomes (4)

  1. Number of wounds healed

    examine the number of wounds that go on to complete healing

    Measured: 12 weeks

  2. Time to healing/complete closure

    examine the time it take for the patient to go onto complete healing

    Measured: 6 weeks

  3. Time to healing/complete closure

    examine the time it take for the patient to go onto complete healing

    Measured: 12 weeks

  4. Cost effectiveness of each treatment modality.

    Examine the cost to achieve closure in the wounds

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2016 (estimated)
  2. Study start31 Aug 2016
  3. Primary completion14 Jun 2018
  4. Study completion14 Jun 2018

Resources

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02870816
Sponsor's protocol ID
MTF-DFU-COMP-01
Status last verified
Dec 2021
First submitted
14 Aug 2016
Last updated
8 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Glat P, Orgill DP, Galiano R, Armstrong D, Serena T, DiDomenico LA, Kaufman J, Carter MJ, Jacobs AM, Zelen CM. Placental Membrane Provides Improved Healing Efficacy and Lower Cost Versus a Tissue-Engineered Human Skin in the Treatment of Diabetic Foot Ulcerations. Plast Reconstr Surg Glob Open. 2019 Aug 30;7(8):e2371. doi: 10.1097/GOX.0000000000002371. eCollection 2019 Aug.

    PubMed 31592387

Questions about this trial

What is this clinical trial studying?

A study testing Tissue Engineered Skin Substitute, Offloading and Amnionic Membrane Graft in people with Diabetic Foot Ulcer, run by Professional Education and Research Institute 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 16 inclusion and 18 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 Dec 2021. 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 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?

The number of participants out of 60 with complete healing of their diabetic foot ulcers as measured by complete epithialization of the foot wound comparing the two active treatment groups (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870816, which also lists 1 linked publication.

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 Dec 2021.

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