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

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: NCT00954343
Recruitment Status : Withdrawn
First Posted : August 7, 2009
Last Update Posted : March 19, 2013
Information provided by:
Technische Universität München

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Chronic Diabetic Foot Ulcers Procedure: Extracorporeal Shock Wave Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1
Study Start Date : August 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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 :
  1. Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
  2. Percentage decrease of ulcer size 6 and 9 weeks after first treatment
  3. Tissue oxygen concentration after shock wave treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00954343

Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Principal Investigator: Hans Gollwitzer, PD Dr., CCRP Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar Identifier: NCT00954343     History of Changes
Other Study ID Numbers: 2456/09
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Keywords provided by Technische Universität München:
Foot Ulcers
Extracorporeal Shockwave
Chronic wound

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