Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT01291160
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients 20-90 years of age with type 1 or type 2 diabetes mellitus with non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers of at least 4 weeks duration, but not greater than 52 weeks, measuring 1 -10 cm2 in area (Area = length x width) 50% at least from 65+ age group
* Any diabetic foot ulcer at or below the malleoli
* Patients with partial amputation up to \& including a TMA
* Subjects; between 20-90 years of age with a diabetic foot ulcer; 50% at least from 65+ age group
* Subjects must have had the wound open for at least 4 weeks from day one on screening visit.
* Subjects wound must be ≥1 cm2 in size at screening visit, but not greater than 10 cm2.
* Subject's ABI should be ≥ 0.7 on the study limb or transcutaneous partial pressure oxygen (TcpO2) \>40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot(biphasic or triphasic waveforms) at screening
* No active malignancy except non-melanoma skin cancer
* Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.
* If patient has had a history of alcohol or substance abuse within 6 months prior to base line period, should provide proof of treatment.
Exclusion Criteria:
* Wounds of duration \>52 weeks
* Evidence of gangrene on any part of affected limb;
* Subjects with active Charcot's foot on the study limb;
* Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis;
* Subjects with infected target ulcers, accompanied by cellulitis, known or suspected osteomyelitis, or other clinical evidence of infection;
* Index ulcer has exposed tendons, ligaments, muscle, or bone.
* ulcers present in between toes
* Target limb is infected at beginning of study
* Must never have had malignancy on study limb
* Oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline.
* Patients with steroids \>7mg dosage are excluded
* Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
* Subject may not be pregnant at the time of treatment.
* Subjects with ulcer that has a total Surface Area of greater than 10 cm2 at Screening Visit as measured by a member of the study staff;
* Subject is undergoing renal dialysis, has known immune insufficiency, other than Diabetes Mellitus
* Ulcers which decrease in area by \>30% during the screening 1-week run-in period
* History of peripheral vascular repair within the 30 days of baseline.
* Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
* No known "patient-reported" alcohol or substance abuse within three months prior to baseline.
* Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
* Subject allergic to a broad spectrum of primary \& secondary dressing materials,including occlusive dressings and the adhesives on such dressings.
* Subject with Chopart amputation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT01291160
Study Brief:
Protocol Section:
NCT01291160