Diabetic Foot Ulcer Clinical Trial
Official title:
The Physiological Effects of Remote Ischemic Conditioning on the Healing of Diabetic Foot Ulcers
Study type: Randomized, double blinded, interventional, single-site study. Two groups: Active
receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC.
Study population: Adults (18 to 90) with diabetes myelitis presenting with diabetic foot
ulcers.
Randomization and sample size: Subjects will be allocated on a 1:1 ratio, yielding a minimum
per protocol population (PP Population) of 15 patients in the Active group and 15 in the
control group.
Study timeline: Total amount of time from the Screening Visit to the Final Visit is
approximately 16 weeks. For patients who meet inclusion criteria, they are randomized into
Active or Control treatment groups. In addition they are stratified into groups based on
wound etiology: neuropathic (defined as insensate at 2 or more of 5 sites verified by
insensitivity to the 5.07 Semmes-Weinstein 10 g monofilament), ischemic (defined as ABI of
0.7 neuro-ischemic (meeting both of above criteria) Subjects will present at DMU Foot and
Ankle Clinic on weeks 0, 3, 6, 9, and 12 for the following measurements: 40mL venous blood
draw (VEGF, SDF1a) 2mm punch biopsy (CD34+) Local wound perfusion (Laser Speckle[FK2] ) Ulcer
size measured by digital planimetry (TissueAnalytics)
n/a
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