NCT02870816

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

August 31, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

1.8 years

First QC Date

August 14, 2016

Last Update Submit

December 1, 2021

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (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

    6 weeks

Secondary Outcomes (4)

  • Number of wounds healed

    12 weeks

  • Time to healing/complete closure

    6 weeks

  • Time to healing/complete closure

    12 weeks

  • Cost effectiveness of each treatment modality.

    12 weeks

Study Arms (2)

Tissue engineered skin substitute

ACTIVE COMPARATOR

Application 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.

Procedure: Tissue Engineered Skin SubstituteDevice: Offloading

Amnionic membrane graft

EXPERIMENTAL

Application 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

Device: OffloadingProcedure: Amnionic Membrane Graft

Interventions

Tissue Engineered Skin SubstitutePROCEDURE

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

Tissue engineered skin substitute
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 graftTissue engineered skin substitute
Amnionic Membrane GraftPROCEDURE

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

Amnionic membrane graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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
  • +1 more criteria

You may not qualify if:

  • 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.
  • Patients who are presently participating in another clinical trial.
  • \. Patients who are currently receiving radiation therapy or chemotherapy.
  • \. Patients with known or suspected local skin malignancy to the index diabetic ulcer.
  • \. Patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
  • \. Patients with uncontrolled 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.
  • \. Patient who are pregnant or breast feeding .
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Martinsville Research Institute

Martinsville, Virginia, 24112, United States

Location

Shenandoah Lower Extremity Research Institute

Roanoke, Virginia, 24013, United States

Location

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

Related Publications (1)

  • 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.

    PMID: 31592387RESULT

Related Links

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Evangelia Chnari, PhD

    Director of Research and Development; Wound Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2016

First Posted

August 17, 2016

Study Start

August 31, 2016

Primary Completion

June 14, 2018

Study Completion

June 14, 2018

Last Updated

December 8, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(3)