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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Intervention Group: Patients will self-administer RIC treatment with the LifeCuff device 3 times a week. Treatment will be delivered at the patient's home and compliance will be monitored by the LifeCuff device. Control Group: Patients undergo typical standard of care treatment. Assessment of Ulcer Closure: Ulcers will be assessed as completely closed by the Principal Investigator through clinical judgement and photographic support. Patients that completely heal their ulcer during the healing period will complete the study and no further blood or tissue measurements will be taken
Change in ulcer area and overall healing rate
Will evaluate healing rates and times for both treatment group and standard of care group using app that can take picture and measure area
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
VEGF
Will evaluate blood levels of VEGF in treatment group and standard of care group
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
SDF1a
Will evaluate blood levels of SDF1a in treatment group and standard of care group
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
CD34+
Will evaluate soft tissue biopsy for presence or absence of CD34+ in treatment group and standard of care group
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
tissue perfusion
Will evaluate overall tissue perfusion using Laser Speckle imaging for both treatment group and standard of care group
Time frame: will be evaluated at 0, 3, 6, 9 and 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.