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

Hadassah Medical Organization300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Diabetic Foot

Interventions

shock wave therapyDEVICE

shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.

dermagold shockwaveDEVICE

shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.

standard of carePROCEDURE

regular care including debridement and bandaging.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

healed ulcer

Time frame: 6 months

Data from ClinicalTrials.gov

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