Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers
NCT ID: NCT01499472
Last Updated: 2011-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2012-01-31
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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shock wave therapy, shortened wound healing time
shock wave therapy
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
dermagold shockwave
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
normal wound care
standard of care intervention
standard of care
regular care including debridement and bandaging.
Interventions
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shock wave therapy
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
dermagold shockwave
shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
standard of care
regular care including debridement and bandaging.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with Diabetes.
3. An Active Diabetic Ulcer larger than 5 cm2
4. Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)\>=0.5
Exclusion Criteria
2. The patient is under another research protocol.
3. One of the following:
A. ABI\<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.
4. The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
5. Sufficient Noncompliant.
6. Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids
18 Years
75 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Ofer Elishuv
Doctor
Other Identifiers
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ofer02-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id