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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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,

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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