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Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
shock wave therapy
dermagold shockwave
standard of care
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed Informed Consent.
  2. Diagnosed with Diabetes.
  3. An Active Diabetic Ulcer larger than 5 cm2
  4. Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)>=0.5

Exclusion Criteria:

  1. Pregnancy.
  2. The patient is under another research protocol.

  3. One of the following:

    A. ABI<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.

  4. The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
  5. Sufficient Noncompliant.
  6. Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    shock wave therapy, shortened wound healing time

    normal wound care

    Arm Description

    standard of care intervention

    Outcomes

    Primary Outcome Measures

    healed ulcer

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2011
    Last Updated
    December 22, 2011
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01499472
    Brief Title
    Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers
    Official Title
    ESWT Treatment of Diabetic Foot VS. Standard Care Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2013 (Anticipated)
    Study Completion Date
    January 2015 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    shock wave therapy, shortened wound healing time
    Arm Type
    Active Comparator
    Arm Title
    normal wound care
    Arm Type
    Other
    Arm Description
    standard of care intervention
    Intervention Type
    Device
    Intervention Name(s)
    shock wave therapy
    Intervention Description
    shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
    Intervention Type
    Device
    Intervention Name(s)
    dermagold shockwave
    Intervention Description
    shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
    Intervention Type
    Procedure
    Intervention Name(s)
    standard of care
    Intervention Description
    regular care including debridement and bandaging.
    Primary Outcome Measure Information:
    Title
    healed ulcer
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed Informed Consent. Diagnosed with Diabetes. An Active Diabetic Ulcer larger than 5 cm2 Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)>=0.5 Exclusion Criteria: Pregnancy. The patient is under another research protocol. One of the following: A. ABI<0.5 C.Significant Arterial-Venous injury. D. Lymphedema. The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date. Sufficient Noncompliant. Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids

    12. IPD Sharing Statement

    Learn more about this trial

    Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers

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