Neuropathic Diabetic Foot Ulcers Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus
Conditions
Interventions
Shock waves and Silvercel dressing versus Silvercel dressing alone. Follow-up in all arms and treatments is for 20 weeks with standard dressing every 3 - 4 days.
Sponsors
University of Bari (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A neuropathic foot plantar ulcer below the malleoli for a period of at least 15 to 30 days with an area wider than 1 cm^2 2. 30 - 70 years old, either sex 3. Diameter of the lesion between 0.5 to 5 cm 4. Diabetes mellitus type I; in insulin treatment since at least 5 years ago
Exclusion criteria
Exclusion criteria: 1. Peripheral vascular disease 2. By-pass 3. Pregnant 4. Coagulation diseases 5. History of neoplasia 6. Other conditions based on the principal investigator's clinical judgement around the ESWT applications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Wound area reductions, measured with the Rhinoceros program 2. Time to complete ulcer healing, measured as the number of days from the start of treatment to the date that a patient achieved complete wound healing. If the healing wasn't within the 20 weeks of the study, the patient was considered as non-healing and the time wasn't registered. 3. Time to complete healing 4. Index of re-epithelisation of the wound area The outcomes were measured every 10 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
Italy
Outcome results
None listed