The management of neuropathic ulcers of the foot in diabetes by shock wave therapy

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Biagio Moretti
Scientific

via Napoli, 215
Bari
70124
Italy

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SWDF
Study objectives	The main objective of the present study was to evaluate healing rates of diabetic foot ulcers during a 20-week period in patients treated by extracorporeal shock wave therapy (ESWT) compared with standard therapy consisting of debridement and Silver dressing.
Ethics approval(s)	Ethics approval received from the local medical ethics committee (Comitato Etico Indipendente Locale Azienda Ospedaliera Ospedale Policlinico Consorziale di Bari) on the 24th June 2008 (ref: 838/CE).
Health condition(s) or problem(s) studied	Neuropathic Diabetic Foot Ulcers
Intervention	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.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/03/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	31/03/2007

via Napoli, 215

Bari
70124
Italy

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan