Status:

UNKNOWN

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

Lead Sponsor:

Hadassah Medical Organization

Conditions:

Diabetic Foot

Eligibility:

All Genders

18-75 years

Phase:

NA

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 wou...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2015

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT01499472

Start Date

January 1 2012

End Date

January 1 2015

Last Update

December 26 2011

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