Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Neogenix, LLC dba Ogenix
Age
20–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
