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Remote Ischemic Conditioning and Diabetic Foot Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567563
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborator:
Iowa State University
Information provided by (Responsible Party):
Katherine Frush, Des Moines University

Brief 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)


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Diabetic Angiopathies Device: Remote Ischemic conditioning (RIC) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Will have intervention group and standard of care group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Physiological Effects of Remote Ischemic Conditioning on the Healing of Diabetic Foot Ulcers
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Remote Ischemic Condition 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

No Intervention: Standard of Care



Primary Outcome Measures :
  1. Change in ulcer area and overall healing rate [ Time Frame: will be evaluated at 0, 3, 6, 9 and 12 weeks ]
    Will evaluate healing rates and times for both treatment group and standard of care group using app that can take picture and measure area


Secondary Outcome Measures :
  1. VEGF [ Time Frame: will be evaluated at 0, 3, 6, 9 and 12 weeks ]
    Will evaluate blood levels of VEGF in treatment group and standard of care group

  2. SDF1a [ Time Frame: will be evaluated at 0, 3, 6, 9 and 12 weeks ]
    Will evaluate blood levels of SDF1a in treatment group and standard of care group

  3. CD34+ [ Time Frame: will be evaluated at 0, 3, 6, 9 and 12 weeks ]
    Will evaluate soft tissue biopsy for presence or absence of CD34+ in treatment group and standard of care group

  4. tissue perfusion [ Time Frame: will be evaluated at 0, 3, 6, 9 and 12 weeks ]
    Will evaluate overall tissue perfusion using Laser Speckle imaging for both treatment group and standard of care group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient any gender between the ages of 18 and under 90 at the time of consent.
  • Target ulcer has a minimum area of 1.0 cm2 and a maximum area of 20.0 cm2, measured at screening after sharp debridement, as assessed by computerized planimetry.
  • Target ulcer open for a minimum of 4 weeks and a maximum of 52 weeks duration prior to the screening visit.
  • Target ulcer is located on the toe or lateral dorsal, or plantar aspect of the foot with no portion on the ankle.
  • Target ulcer is Grade IC (ischemic, non-infected superficial wound) or IIC (ischemic non-infected wound penetrating to tendon or capsule), according to the University of Texas Diabetic Wound Classification system.
  • Adequate perfusion without critical limb ischemia, confirmed by vascular assessment of the affected foot through any of the following methods: ABI >0.7
  • Confirmed diagnosis of type 1 or 2 diabetes mellitus
  • Patient has a glycated hemoglobin A1c (HbA1c) level of less than 12%
  • If patient has two or more ulcers, they must be separated by at least 2 cm and the largest one will be included as the study DFU though all will be similarly treated
  • Patient is willing to use prescribed off-loading method during the whole duration of the study
  • Patient available for the entire study period all follow up visit requirements, and able and willing to adhere to protocol requirements
  • Patient able and willing to give written informed consent

Exclusion Criteria:

  • Target ulcer is less than 1.0 cm2 measured at consent after sharp debridement
  • Target ulcer is due to a non-diabetic etiology
  • Presence in target ulcer of cellulitis, osteomyelitis or other clinical evidence of infection at time of enrollment.
  • Presence of any foot ulcer (whether or not on the target foot) for which systemic antibiotic treatment is required.
  • A history of more than 8 weeks' treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or treatments with such medications during the screening period.
  • Patients with an amputation on the affected foot, if it impedes proper offloading of the target DFU.
  • Patients with active Charcot foot, or inactive Charcot foot, if it impedes proper offloading of the target DFU.
  • Women who are pregnant or considering becoming pregnant within the next 6 months.
  • Patients with concurrent severe psychiatric disease that in the opinion of the investigator would impede participation in the trial.
  • Presence of subject having recent or current alcohol or drug abuse.
  • Patients with severe kidney disease who are currently untreated or awaiting dialysis treatment
  • Participation in another study involving treatment with an investigational product within the previous 30 days.
  • Any other medical or psychological conditions that, in the opinion of the Investigator may make patient's participation unreliable or may interfere with study assessments.
  • Patients with history of radiation to the ulcer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567563


Contacts
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Contact: Katherine Frush, DPM 515-271-1731 katherine.frush@dmu.edu

Sponsors and Collaborators
Des Moines University
Iowa State University
Investigators
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Principal Investigator: Katherine Frush, DPM Des Moines University
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Responsible Party: Katherine Frush, Associate Professor, Des Moines University
ClinicalTrials.gov Identifier: NCT04567563    
Other Study ID Numbers: IRB-2020-3
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Frush, Des Moines University:
remote ischemic conditioning
diabetic foot ulcer
diabetic angiopathy
Additional relevant MeSH terms:
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Diabetic Foot
Diabetic Angiopathies
Foot Ulcer
Ulcer
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases