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

• Conditions: chronic diabetic foot ulcer; footwound caused by diabetes; 10012653; 10014982

• Registration Number: NL-OMON56830
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 54

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
• Two missed ESWT treatments
• Participation in an ongoing other clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified