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| Name | Class |
|---|---|
| Iowa State University | OTHER |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Ischemic Condition | Active Comparator |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Ischemic conditioning (RIC) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | will be evaluated at 0, 3, 6, 9 and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VEGF | Will evaluate blood levels of VEGF in treatment group and standard of care group | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katherine Frush, DPM | Contact | 515-271-1731 | katherine.frush@dmu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katherine Frush, DPM | Des Moines University | Principal Investigator |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003925 | Diabetic Angiopathies |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
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Will have intervention group and standard of care group
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| 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 | 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 | will be evaluated at 0, 3, 6, 9 and 12 weeks |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |