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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00954343
First received: July 31, 2009
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Chronic Diabetic Foot Ulcers
 Procedure: Extracorporeal Shock Wave

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 0
Study Start Date: August 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954343

Locations
Germany
Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar
Munic, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Hans Gollwitzer, PD Dr., CCRP Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00954343     History of Changes
Other Study ID Numbers: 2456/09
Study First Received: July 31, 2009
Last Updated: March 18, 2013
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 23, 2013