Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating 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. Read our disclaimer for details. Identifier: NCT01499472
Recruitment Status : Unknown
Verified August 2011 by Ofer Elishuv, Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : December 26, 2011
Last Update Posted : December 26, 2011
Information provided by (Responsible Party):
Ofer Elishuv, Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Device: shock wave therapy Device: dermagold shockwave Procedure: standard of care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: ESWT Treatment of Diabetic Foot VS. Standard Care Trial
Study Start Date : January 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: shock wave therapy, shortened wound healing time Device: shock wave therapy
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
Device: dermagold shockwave
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
normal wound care
standard of care intervention
Procedure: standard of care
regular care including debridement and bandaging.

Primary Outcome Measures :
  1. healed ulcer [ Time Frame: 6 months ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Ofer Elishuv, Doctor, Hadassah Medical Organization Identifier: NCT01499472     History of Changes
Other Study ID Numbers: ofer02-HMO-CTIL
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: December 26, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies