CompletedNot Applicable

Phase IV Study to Evaluate the Efficacy of AMNIOEXCEL in Diabetic Foot Ulcers

United States29 participantsStarted 2014-07

Plain-language summary

The primary goal of the study is to demonstrate the increased rate of complete wound closure by AMNIOEXCEL® compared to routine care in patients with chronic diabetic foot ulcers

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. an ambulatory person at least 18 years of age at the time of informed consent.
✓. type 1 or type 2 diabetes mellitus.
✓. glycosylated hemoglobin (HbA1c) of ≤12%
✓. at least one wound that is/has:
✓. adequate circulation to the affected extremity
✓. serum creatinine of \<3.0mg/dl.

Exclusion criteria

✕. participated in another clinical trial within 30 days prior to consent,
✕. Active Charcot deformity of the study foot (i.e. erythematous, warm, edematous and actively remodeling)
✕. receiving radiation or chemotherapy of any kind,
✕. known or suspected malignancy of current ulcer,
✕. pregnant or breast feeding,
✕. an active malignant disease,
✕. receiving hemo- or peritoneal dialysis,
✕. sickle cell anemia or Raynaud's syndrome,

What they're measuring

Proportion of patients with complete wound closure (i.e. complete skin re-epithelialization without drainage or dressing requirements) at 6 weeks after initiation of study treatment

Timeframe: 8 weeks

Trial details

NCT IDNCT02209051

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Diabetic Foot Ulcers trials