Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/07/2008
Date assigned
29/09/2008
Last edited
29/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Biagio Moretti

ORCID ID

Contact details

via Napoli
215
Bari
70124
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

838/CE

Study information

Scientific title

Acronym

SWDF

Study hypothesis

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

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).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2006

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Italy

Trial participating centre

via Napoli, 215
Bari
70124
Italy

Sponsor information

Organisation

University of Bari (Italy)

Sponsor details

Piazza G. Cesare
11
Bari
70124
Italy

Sponsor type

University/education

Website

http://www.uniba.it/

Funders

Funder type

University/education

Funder name

University of Bari (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes