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Status unknownNCT01499472Updated Dec 26, 2011

Comparing the Expected Benefit of Extra-corporeal-shockwave Therapy (ESWT) Treatment to Standard Care in Treating Diabetic Foot Ulcers

An interventional study of shock wave therapy and dermagold shockwave in Diabetic Foot, sponsored by Hadassah Medical Organization. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-12-26.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetic Foot

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03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's planned enrollment of 300 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed Informed Consent.
  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

Exclusion Criteria:

  1. Pregnancy.
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    shock wave therapy, shortened wound healing time

    Device: shock wave therapy · Device: dermagold shockwave

  • Other
    normal wound care

    standard of care intervention

    Procedure: standard of care

Interventions

  • Deviceshock wave therapy

    shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.

  • Devicedermagold shockwave

    shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.

  • Procedurestandard of care

    regular care including debridement and bandaging.

06

What researchers measure

Primary outcomes

  1. healed ulcer

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01499472
Lead sponsor
Hadassah Medical Organization
Responsible party
Ofer Elishuv (Doctor, Hadassah Medical Organization) — Principal investigator
First posted
Dec 26, 2011
Start date
Jan 2012
Primary completion
Jan 2013 (estimated)
Completion
Jan 2015 (estimated)
Last update
Dec 26, 2011
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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