NCT01499472

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

December 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

September 4, 2011

Last Update Submit

December 22, 2011

Conditions

Diabetic Foot

Outcome Measures

Primary Outcomes (1)

  • healed ulcer

    6 months

Study Arms (2)

shock wave therapy, shortened wound healing time

ACTIVE COMPARATOR
Device: shock wave therapyDevice: dermagold shockwave

normal wound care

OTHER

standard of care intervention

Procedure: standard of care

Interventions

shock wave therapyDEVICE

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

shock wave therapy, shortened wound healing time
dermagold shockwaveDEVICE

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

shock wave therapy, shortened wound healing time
standard of carePROCEDURE

regular care including debridement and bandaging.

normal wound care

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent.
  • Diagnosed with Diabetes.
  • An Active Diabetic Ulcer larger than 5 cm2
  • Sufficient limb perfusion.(e.g no compartment syndrome ankle Brachial Index (ABI)\>=0.5

You may not qualify if:

  • Pregnancy.
  • The patient is under another research protocol.
  • One of the following:
  • A. ABI\<0.5 C.Significant Arterial-Venous injury. D. Lymphedema.
  • The patient underwent Chemotherapy or Radiotherapy 60 days or less prior to recruitment date.
  • Sufficient Noncompliant.
  • Sickle Cell Anemia, HIV, Immunodeficiency, HgB Anemia, DVT, Chronic Renal Failure, Systemic use of Steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Foot

Interventions

Extracorporeal Shockwave TherapyStandard of Care

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 4, 2011

First Posted

December 26, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2015

Last Updated

December 26, 2011

Record last verified: 2011-08