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

Technical University of Munich

Status: Withdrawn

Conditions: Chronic Diabetic Foot Ulcers

Treatments: Procedure: Extracorporeal Shock Wave

Study type: Interventional

Funder types: Other

Identifiers

NCT00954343

2456/09

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 5 patient groups

Group I

Experimental group

Treatment:

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Group II

Experimental group

Treatment:

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Group III

Experimental group

Treatment:

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Group IV

Experimental group

Treatment:

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Procedure: Extracorporeal Shock Wave

Group V

No Intervention group