Shockwave Treatment of Diabetic Foot Ulcer: Step I

Chronic Diabetic Foot Ulcers Clinical Trial

— STUF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00954343
• Other study ID #: 2456/09
• Status: Withdrawn
• Phase: N/A
• First received: July 31, 2009
• Last updated: March 18, 2013
• Start date: August 2009

Study information

• Verified date: March 2013
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcers
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

Procedure:
• Extracorporeal Shock Wave

• Extracorporeal Shock Wave

• Extracorporeal Shock Wave

• Extracorporeal Shock Wave

Locations

Country	Name	City	State
Germany	Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar	Munic	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
Secondary	Percentage decrease of ulcer size 6 and 9 weeks after first treatment
Secondary	Tissue oxygen concentration after shock wave treatment