chronic diabetic foot ulcer footwound caused by diabetes
Conditions
Interventions
The patients will receive 12 (placebo) ESWT treatments in addition to standard
care. Standard care includes debridement, diabetic control, wound care,
off-loading and footwear modification for press
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion 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 0.7 • Toe systolic pressure > 50 mmHg • Participants are mentally competent to understand and sign a Dutch informed consent form themselves
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is percentage of reduction in wound surface area | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are time to complete healing, recurrence rate and quality of life. | — |
Countries
Netherlands
Outcome results
None listed