The management of neuropathic ulcers of the foot in diabetes by shock wave therapy
| ISRCTN | ISRCTN21800909 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21800909 |
| Secondary identifying numbers | 838/CE |
- Submission date
- 02/07/2008
- Registration date
- 29/09/2008
- Last edited
- 29/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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
Contact information
Prof Biagio Moretti
Scientific
Scientific
via Napoli, 215
Bari
70124
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 outcome measures | No secondary outcome measures |
| Overall study start date | 01/10/2006 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Italy
Study participating centre
via Napoli, 215
Bari
70124
Italy
70124
Italy
Sponsor information
University of Bari (Italy)
University/education
University/education
Piazza G. Cesare, 11
Bari
70124
Italy
| Website | http://www.uniba.it/ |
|---|---|
"ROR" |
https://ror.org/027ynra39 |
Funders
Funder type
University/education
University of Bari (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
