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Clinical Trials/NL-OMON56830
NL-OMON56830
Not yet recruiting
Not Applicable

Treatment of chronic diabetic foot ulcers with Extracorporeal Shock Wave Therapy (ESWT) - a double-blind randomized controlled trial - Shock Wave for diabetic foot ulcers

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
chronic diabetic foot ulcer
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
54
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older
  • Diabetes mellitus type I or 2
  • Uni\- or bilateral chronic foot ulcers which have not healed for 6 weeks
  • Grade 1A or 2A ulcer according to the Texas Diabetic Foot Wound
  • Classification System
  • Diameter of the ulcer \> 0\.5 cm and \< 5 cm on the plantar side of the foot
  • Ankle\-brachial index \> 0\.7
  • Toe systolic pressure \> 50 mmHg
  • Participants are mentally competent to understand and sign a Dutch informed
  • consent form themselves

Exclusion Criteria

  • History of neoplasia or malignancy near the chronic diabetic foot ulcer
  • Pregnancy
  • Skeletal immaturity which has an influence on the ability to walk
  • Sign of acute local infection demanding the use of systemic antibiotics or
  • the need for amputation
  • Osteomyelitis or gangrene in the affected extremity
  • Severe anemia (Hb \< 7,0g/dl)
  • Ankle brachial index \< 0\.7
  • Toe systolic pressure \< 50 mmHg
  • Any history with ESWT

Outcomes

Primary Outcomes

Not specified

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