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Remote Ischemic Conditioning and Diabetic Foot Ulcers

NCT04567563 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-28

No results posted yet for this study

Summary

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)

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Angiopathies

Interventions

DEVICE

Remote Ischemic conditioning (RIC)

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

Sponsors & Collaborators

  • Iowa State University

    collaborator OTHER

  • Des Moines University

    lead OTHER

Principal Investigators

  • Katherine Frush, DPM · Des Moines University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2022-11-30
Completion
2022-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04567563 on ClinicalTrials.gov