Shockwave Treatment of Diabetic Foot Ulcer: Step I | NCT00954343

Studies
Shockwave Treatment of Diabetic Foot Ulcer: Step I

NCT00954343

Sponsor

Technical University of Munich

Status

Withdrawn

Last Update Posted

Mar 19, 2013Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Chronic Diabetic Foot Ulcers

Interventions

Extracorporeal Shock Wave
Extracorporeal Shock Wave
Extracorporeal Shock Wave
Extracorporeal Shock Wave

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 31, 2009

First Submission Date that Met QC Criteria

Aug 6, 2009

First Posted Date

Aug 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2013

Last Update Posted Date

Mar 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group I	Experimental	Procedure: Extracorporeal Shock Wave
Group II	Experimental	Procedure: Extracorporeal Shock Wave
Group III	Experimental	Procedure: Extracorporeal Shock Wave
Group IV	Experimental	Procedure: Extracorporeal Shock Wave
Group V	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extracorporeal Shock Wave	Procedure		Group I
Extracorporeal Shock Wave

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Gollwitzer, PD Dr., CCRP	Klinik für Orthopädie und Unfallchirurgie Klinikum rechts der Isar	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Orthopädie und Unfallchirurgie, Klinikum rechts der Isar		Munich	Bavaria	81675	Germany

Condition Browse Module

MeSH Terms

ID	Term
D016523	Foot Ulcer

Ancestor Terms

ID	Term
D005534	Foot Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007871	Leg Ulcer

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000074059	Extracorporeal Shockwave Therapy

Ancestor Terms

ID	Term
D014464	Ultrasonic Therapy
D003972	Diathermy
D006979	Hyperthermia, Induced
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided