NCT00366132

Brief Summary

The purpose of this clinical study is to compare the safety and effectiveness of shockwave treatment combined with standard-of-care treatment, to standard-of-care treatment alone to induce healing of a chronic plantar foot ulcer in subjects with diabetes mellitus. For the purpose of this study, the definition of plantar foot ulcer is a wound or open sore that involves the plantar(bottom) aspect of the foot, and the definition of chronic is a duration of 6 weeks or greater with a lack of response to treatment.

Trial Health

55
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Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

5 active sites

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

Study Start

First participant enrolled

March 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

August 17, 2006

Last Update Submit

August 17, 2006

Conditions

Chronic Diabetic Foot Ulcers

Keywords

DiabeticFoot UlcersTRTDermaGoldShockwaveESWTDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Time to Complete Wound Healing

Secondary Outcomes (6)

  • o A comparison of the total number of subjects with a final status of "Healed" in the active versus control group

  • o Partial healing at 12 weeks post treatment ((size of wound compared to baseline));

  • o Results of quantitative wound cultures (Ulcers with a quantitative wound culture with a bacterial count greater than 105 per gram of tissue will be defined as an infected ulcer);

  • o The percentage of the wound that has healed

  • o The number of shock wave treatments performed

  • +1 more secondary outcomes

Interventions

Extracorporeal ShockwavesDEVICE

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of a single chronic plantar foot ulcer that has persisted for a minimum of 6 weeks duration
  • History of Type 2 diabetes mellitus; (track/ask if insulin dependent)
  • Capable of wound care at home;
  • The ulcer measures \> 1 cm and \<4 cm at any dimension
  • The ulcer is Stage 1 or 2A according to the classification system described by Lavery et al.
  • Stage 1 - superficial wounds through the epidemis or epidermis and dermis that did not penetrate to tendon, capsule or bone.
  • Stage 2A - Clean wounds that penetrated to tendon or capsule.
  • Palpable pedal pulse in the affected leg OR peripheral vascular disease evaluation demonstrating acceptable blood supply to affected foot;
  • Subjects age \> 18 years;
  • The Investigator has completed a medical history and a physical examination to assure that the subject meets all study enrollment criteria;
  • The subject is willing and able to read, understand and sign the study specific informed consent form; and
  • The subject agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the wound (e.g., wet to wet dressings, orthotics) and all follow up visit requirements.

You may not qualify if:

  • Pregnancy
  • Type I diabetes
  • Plantar foot ulcer extends to and /or involves the bone or joint;
  • Ulcers are present on both feet
  • Multiple ulcers on the foot
  • Clinical evidence of cellulitis at the ulcer site or surrounding area;
  • Ulcers that have purulent exudates or malodorous exudates on visual examination
  • Diagnosis of a chronic plantar foot ulcer that has persisted for \>1 year.
  • Peripheral vascular disease per the study enrollment work-up requiring vascular surgery intervention.
  • ABI (Ankle Brachial Index) \< 0.6 Ulcer debridement under anesthesia in OR required within the 2 week observation phase,
  • Lower extremity revascularization procedure (e.g. PTA, graft, etc.) within eight (8) weeks of the study screening visit.
  • Uncorrected biomechanical abnormalities that cause or contribute to the affected lower extremity ulcer; (e.g. tight Achilles tendon, hammer toe, Charcot foot etc.)
  • Surgical procedure to correct biomechanical abnormities (e.g., lengthening of the Achilles tendon. correction of hammer toe, Charcot foot correction) within eight (8) weeks of the study screening visit;
  • Deep vein thrombosis within 6 months of study screening visit;
  • Clinical evidence of lymphadema;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Calvary Hospital

The Bronx, New York, 10461, United States

RECRUITING

Akron General

Akron, Ohio, 44307, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Podiatry Group of South Texas

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Foot UlcerDiabetes Mellitus

Condition Hierarchy (Ancestors)

Foot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLeg UlcerSkin UlcerGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

March 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(5)