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

This study is not yet open for participant recruitment.
Verified August 2011 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Ofer Elishuv, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01499472
First received: September 4, 2011
Last updated: December 22, 2011
Last verified: August 2011
  Purpose

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 Intervention
Diabetic Foot
Device: shock wave therapy
Device: dermagold shockwave
Procedure: standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: ESWT Treatment of Diabetic Foot VS. Standard Care Trial

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • healed ulcer [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Ofer Elishuv, Doctor, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01499472     History of Changes
Other Study ID Numbers: ofer02-HMO-CTIL
Study First Received: September 4, 2011
Last Updated: December 22, 2011
Health Authority: Israel:Ministry of Health - Director General

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

ClinicalTrials.gov processed this record on April 22, 2014