Shockwave Treatment of Diabetic Foot Ulcer: Step I (STUF)

March 18, 2013 updated by: Technical University of Munich

Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1

Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc). In recent years, encouraging results have been reported concerning the effect of the shock-wave on chronic wounds. It has been reported that healing time can be considerably shortened if shock-waves are applied to the wound in addition to conventional wound treatment. Yet, randomized, controlled, prospective trials are missing.

In this study, the effect of shock-waves on diabetic foot ulcer shall be assessed.

The study is composed of 5 groups of which 4 groups receive shock wave treatments (each with a different protocol). One group serves as an untreated control group. All groups get standardized wound treatment and wound dressing.

That shock-wave application protocol that shows the best results (rate of completely healed ulcer, most decrease of ulcer size) shall be tested in a further, sufficiently dimensioned, two-armed, randomized controlled trial (RCT).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munic, Bavaria, Germany, 81675
        • Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 and older
  • Diabetes Type I or II
  • Chronic ulcer on the foot
  • Ulcer present for at least 6 weeks
  • Wagner Grade 1 or 2

Exclusion Criteria:

  • Chronic rest pain
  • Critical ischemia
  • Gangrene
  • Ankle-Arm-Index < 0,5
  • Critical ischemia treated within 6 weeks before possible enrollment
  • Ulcer of Grade 3 or worse according to the Wagner Classification
  • Osteomyelitis
  • Affection of toes
  • Necessity of surgical intervention
  • Malalignment of the foot sustaining the ulcer
  • Treatment of Ulcer with Prostaglandins or vasodilatators within the last 2 weeks
  • Current therapy with corticoids
  • Infection with HIV; Hepatitis
  • Suppression of immune system (due to illness or medication)
  • Medication with Vitamin-K-Antagonists
  • Known hemophilia
  • Sever Hypalbuminemia < 2 g/dl
  • Severe anemia
  • Ulcer other than of diabetic origin
  • Pregnant or breast-feeding women
  • Known coagulopathies
  • Implants such as artificial heart valves, joint replacement, bone replacement, osteosynthesis material
  • Patients participating on other studies
  • Chemotherapy within the last 60 days
  • Mentally disabled patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
Procedure: Extracorporeal Shock Wave
Experimental: Group II
Procedure: Extracorporeal Shock Wave
Experimental: Group III
Procedure: Extracorporeal Shock Wave
Experimental: Group IV
Procedure: Extracorporeal Shock Wave
No Intervention: Group V

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage decrease of ulcer size twelve weeks after treatment begin (i.e. first shock wave treatment) compared to the baseline (ulcer size at first treatment)

Secondary Outcome Measures

Outcome Measure
Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
Percentage decrease of ulcer size 6 and 9 weeks after first treatment
Tissue oxygen concentration after shock wave treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Hans Gollwitzer, PD Dr., CCRP, Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

August 6, 2009

First Posted (Estimate)

August 7, 2009

Study Record Updates

Last Update Posted (Estimate)

March 19, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2456/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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