NCT01552499

Brief Summary

The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

5 months

First QC Date

March 6, 2012

Last Update Submit

August 13, 2015

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

  • The proportion of completely healed ulcers in patients treated with amniotic membrane vs. standard of care

    12 week

Secondary Outcomes (2)

  • Percent change in wound area

    4 week

  • Mean time to complete healing

    Up to 12 weeks

Study Arms (2)

Control

OTHER
Other: Standard of care

Treatment

EXPERIMENTAL
Other: Standard of careOther: Applications of EpiFix

Interventions

Standard of careOTHER
ControlTreatment
Applications of EpiFixOTHER
Treatment

Eligibility Criteria

Age18 Years+
Sexall
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 direction, with documented failure of prior treatment to heal the wound.
  • Patient's ulcer must exhibit no clinical signs of infection.
  • 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 Creatine less then 3.0mg/dl
  • HbA1c less than 12%
  • 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, 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

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.
  • 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.
  • 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 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.
  • Patient who are pregnant or breast feeding.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Charles M. Zelen, DPM

    Professional Education and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 17, 2015

Record last verified: 2015-08

Locations

US(1)