search
Back to results

Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcers

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Extracorporeal Shockwave Therapy and debridement
debridement and cleaning
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcers

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • Inclusion Criteria:

    1. Chronic non-healing diabetic foot ulcers for more than 2 months.
    2. Age 18-80 years
    3. Ankle Brachial Index (ABI) ≥0.6
    4. Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm
    5. The target ulcer is up to Wagner's grade 3
    6. Albumin level ≥25g/L
    7. Hemoglobin level ≥90g/L
    8. Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2
    9. The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements

  • Exclusion Criteria:

    1. Pregnancy or lactation
    2. ABI <0.6
    3. The long diameter of the target ulcer is >7cm and the short diameter is <1cm
    4. The target ulcer is of Wagner's grade 4 or above
    5. Severe Hypoalbuminemia <25g/L
    6. Severe anemia, Hemoglobin level <90g/L
    7. eGFR <30ml/min/1.73m2
    8. Patients suffering from acute Charcot foot
    9. Severe edema of the treated limb
    10. Patient with present malignancy or past malignancy in the treated area
    11. Systemic chemotherapy/ radiation treatment within the last 6 months
    12. Deep vein thrombosis within the last 6 months

    13. Any other experimental treatment or participation in other studies

      -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Extracorporeal Shockwave Therapy and debridement

    debridement and cleansing.

    Arm Description

    The treatment will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing before each treatment. The transducer device will be positioned against the lesion area and shockwaves will be delivered at a gradually increasing energy, with a maximum energy level of 0.09mJ/mm2

    The standard treatment to the control group and the treatment group will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing. The physician will treat the patient in regard to his medical state: antibiotic medication if needed, dressing and off loading with Orthotic devices

    Outcomes

    Primary Outcome Measures

    To assess initial closure rate of the wound 4 weeks after the last treatment session, as compared to the control group receiving conventional standard of care.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2016
    Last Updated
    February 21, 2016
    Sponsor
    Hadassah Medical Organization
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02691234
    Brief Title
    Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    April 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis. The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Ulcers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Extracorporeal Shockwave Therapy and debridement
    Arm Type
    Experimental
    Arm Description
    The treatment will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing before each treatment. The transducer device will be positioned against the lesion area and shockwaves will be delivered at a gradually increasing energy, with a maximum energy level of 0.09mJ/mm2
    Arm Title
    debridement and cleansing.
    Arm Type
    Active Comparator
    Arm Description
    The standard treatment to the control group and the treatment group will be performed as an outpatient care procedure with no anesthesia. Patients will undergo wound debridement and cleansing. The physician will treat the patient in regard to his medical state: antibiotic medication if needed, dressing and off loading with Orthotic devices
    Intervention Type
    Device
    Intervention Name(s)
    Extracorporeal Shockwave Therapy and debridement
    Intervention Type
    Other
    Intervention Name(s)
    debridement and cleaning
    Primary Outcome Measure Information:
    Title
    To assess initial closure rate of the wound 4 weeks after the last treatment session, as compared to the control group receiving conventional standard of care.
    Time Frame
    four weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic non-healing diabetic foot ulcers for more than 2 months. Age 18-80 years Ankle Brachial Index (ABI) ≥0.6 Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm The target ulcer is up to Wagner's grade 3 Albumin level ≥25g/L Hemoglobin level ≥90g/L Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2 The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements Exclusion Criteria: Pregnancy or lactation ABI <0.6 The long diameter of the target ulcer is >7cm and the short diameter is <1cm The target ulcer is of Wagner's grade 4 or above Severe Hypoalbuminemia <25g/L Severe anemia, Hemoglobin level <90g/L eGFR <30ml/min/1.73m2 Patients suffering from acute Charcot foot Severe edema of the treated limb Patient with present malignancy or past malignancy in the treated area Systemic chemotherapy/ radiation treatment within the last 6 months Deep vein thrombosis within the last 6 months Any other experimental treatment or participation in other studies -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers

    We'll reach out to this number within 24 hrs