Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers
|ClinicalTrials.gov Identifier: NCT01499472|
Recruitment Status : Unknown
Verified August 2011 by Ofer Elishuv, Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : December 26, 2011
Last Update Posted : December 26, 2011
Hadassah Medical Organization
Information provided by (Responsible Party):
Ofer Elishuv, Hadassah Medical Organization
The purpose of this study is to determine if Extra-corporeal-shockwave Therapy (ESWT) added to standard of care wound therapy significantly improves time to complete wound healing in diabetic foot wounds.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot||Device: shock wave therapy Device: dermagold shockwave Procedure: standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||ESWT Treatment of Diabetic Foot VS. Standard Care Trial|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2015|
|Active Comparator: shock wave therapy, shortened wound healing time||
Device: shock wave therapy
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.Device: dermagold shockwave
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
normal wound care
standard of care intervention
Procedure: standard of care
regular care including debridement and bandaging.
Primary Outcome Measures :
- healed ulcer [ Time Frame: 6 months ]
No Contacts or Locations Provided