Shockwave Treatment of Diabetic Foot Ulcer: Step I

Study Overview
=================
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).

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

Conditions
-----------------
Chronic Diabetic Foot Ulcers

Intervention / Treatment
-----------------
* Procedure: Extracorporeal Shock Wave
* Procedure: Extracorporeal Shock Wave
* Procedure: Extracorporeal Shock Wave
* Procedure: Extracorporeal Shock Wave


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br> | Procedure: Extracorporeal Shock Wave<br> <br> |
| Experimental: Group II<br> | Procedure: Extracorporeal Shock Wave<br> <br> |
| Experimental: Group III<br> | Procedure: Extracorporeal Shock Wave<br> <br> |
| Experimental: Group IV<br> | Procedure: Extracorporeal Shock Wave<br> <br> |
| No Intervention: Group V<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Foot Ulcers, Extracorporeal Shockwave, Chronic wound