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Amniotic Membrane Graft
Amniotic Membrane Graft for Diabetic Foot Ulcers
N/A
Waitlist Available
Led By Lawrence Didomenico, DPM
Research Sponsored by Lower Extremity Institute for Research and Therapy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient's ulcer must be diabetic in origin and larger than 1 cm2
Patient's ulcer must exhibit no clinical signs of infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial compares the effectiveness of human amniotic membrane to standard wound care for non healing diabetic foot wounds.
Who is the study for?
Adults over 18 with diabetic foot ulcers larger than 1 cm2 that have not healed in at least four weeks despite treatment. Participants must show no signs of infection, have controlled diabetes (HbA1c ≤12%), and adequate blood flow to the affected limb. Excluded are those with poor medical compliance, hypersensitivity to trial materials, pregnant or breastfeeding women, certain medication users, and those with specific health conditions.Check my eligibility
What is being tested?
The study compares the effectiveness of human amniotic membrane grafts versus standard wound care for treating non-healing diabetic foot wounds over a period of 12 weeks. The goal is to see if this new method can improve healing rates.See study design
What are the potential side effects?
While the trial description does not specify side effects, potential risks may include local reactions at the application site such as redness or irritation, infection risk due to open wounds, and possible allergic reactions to graft material.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ulcer is diabetic and larger than 1 cm2.
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My ulcer shows no signs of infection.
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I have a wound on my foot below the ankle that is caused by nerve damage.
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My leg's blood flow is confirmed to be adequate by recent tests.
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My ulcer has not healed in 4 weeks despite treatment.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of ulcers completely healed by amniotic memrane versus standard care
Secondary outcome measures
Proportion of ulcers healed by amniotic membrane versus standard care
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Surgical debridement of diabetic foot ulcer, followed by collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice offloading, reassessment weekly at office visit
Group II: Amniotic Membrane / AmniobandExperimental Treatment2 Interventions
Application of Amnioband with dressing application, to be changed weekly following surgical debridement. Patient will practice offloading. If the ulcer is not closed completely Amnioband will be applied weekly at weeks 2-11
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Offloading
2014
N/A
~490
Dressing Application
2016
Completed Phase 4
~260
Find a Location
Who is running the clinical trial?
Lower Extremity Institute for Research and TherapyLead Sponsor
Musculoskeletal Transplant FoundationOTHER
20 Previous Clinical Trials
1,550 Total Patients Enrolled
2 Trials studying Diabetic Foot
140 Patients Enrolled for Diabetic Foot
Lawrence Didomenico, DPMPrincipal Investigatormedical director
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used any growth factor treatments for my wound in the last 30 days.My ulcer is diabetic and larger than 1 cm2.Your kidney function, as measured by a blood test called creatinine, has been very poor in the past six months.You have a history of not following your medical treatments as prescribed.I am on medication that affects my immune system.My ulcer shows no signs of infection.I have a deep ulcer that reaches to my tendon, muscle, or bone.I am currently undergoing radiation therapy or chemotherapy.Your serum creatinine level has been less than 3.0mg/dl in the past six months.My diabetic foot ulcer is larger than 25 cm2.My HbA1c level was over 12% in the last 3 months, indicating my diabetes is not well-controlled.I am currently taking Cox-2 inhibitor medication.I have or might have skin cancer near my diabetic foot ulcer.I have a wound on my foot below the ankle that is caused by nerve damage.My ulcer has not healed in 4 weeks despite treatment.My wound has been stable for two weeks before the trial.My leg's blood flow is confirmed to be adequate by recent tests.I currently have an infection at the site.I am 18 years old or older.I do not have any conditions that could affect my healing by limiting blood supply.Your HbA1c level is 12% or less in the last three months.You have wounds that have not healed for more than a year.My surgical site cannot be improved with surgery to restore blood flow.I have been diagnosed with an autoimmune connective tissue disease.I have other wounds, but they are not close to my study wound.My wounds improved by more than 20% in the first two weeks with standard care.You have been diagnosed with Type 1 or Type 2 diabetes according to the American Diabetes Association guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Amniotic Membrane / Amnioband
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently recruiting participants?
"According to information on clinicaltrials.gov, this specific study is not currently soliciting new patients; it was initially posted in March 2015 and lastly revised in August 2016. Nevertheless, there are still 390 other studies seeking enrolment at the moment."
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