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

Primary Purpose

Chronic Diabetic Foot Ulcers

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Extracorporeal Shock Wave
Extracorporeal Shock Wave
Extracorporeal Shock Wave
Extracorporeal Shock Wave
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diabetic Foot Ulcers focused on measuring Foot Ulcers, Extracorporeal Shockwave, Chronic wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Group I

Group II

Group III

Group IV

Group V

Arm Description

Outcomes

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

Full Information

First Posted
July 31, 2009
Last Updated
March 18, 2013
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00954343
Brief Title
Shockwave Treatment of Diabetic Foot Ulcer: Step I
Acronym
STUF
Official Title
Shockwave Treatment of Diabetic Foot Ulcer. A Prospective, Controlled, Randomized Trial. Step 1
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Withdrawn
Study Start Date
August 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diabetic Foot Ulcers
Keywords
Foot Ulcers, Extracorporeal Shockwave, Chronic wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Title
Group II
Arm Type
Experimental
Arm Title
Group III
Arm Type
Experimental
Arm Title
Group IV
Arm Type
Experimental
Arm Title
Group V
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock Wave
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock Wave
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock Wave
Intervention Type
Procedure
Intervention Name(s)
Extracorporeal Shock Wave
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Rate of completely healed ulcer 6, 9 and 12 weeks after first treatment
Title
Percentage decrease of ulcer size 6 and 9 weeks after first treatment
Title
Tissue oxygen concentration after shock wave treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Gollwitzer, PD Dr., CCRP
Organizational Affiliation
Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar
City
Munic
State/Province
Bavaria
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

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Shockwave Treatment of Diabetic Foot Ulcer: Step I

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