Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Tissue Regeneration Technologies.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tissue Regeneration Technologies
ClinicalTrials.gov Identifier:
NCT00366132
First received: August 17, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Diabetic Foot Ulcers
Device: Extracorporeal Shockwaves
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DermaGold Indicated for Use of Shockwave Treat of Diabetic Foot Ulcers in Patients With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Tissue Regeneration Technologies:

Primary Outcome Measures:
  • Time to Complete Wound Healing

Secondary Outcome Measures:
  • 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
  • o Durability of wound closure (i.e., status of wound at one week following determination of “healed”)

Estimated Enrollment: 200
Study Start Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • Active or previous (within 60 days prior to the study screening visit) chemotherapy;
  • Treatment of the plantar foot ulcer with growth factors, prostaglandin therapy or vasodilator therapy during the 2 week observation phase.
  • Subject on steroid therapy
  • Sickle cell anemia
  • Infection with Human Immunodeficiency Virus
  • Immunodeficiency disorders
  • Severe protein malnutrition – serum albumin < 2.0g/dl
  • Severe anemia - Hgb < 7 g/dl (males) or < 6.5 (females)
  • Recent treatment (within 60 days prior to the study screening visit) with immunosuppresants, radiation, or biologically active cellular / acellular products;
  • Current history of substance abuse.
  • Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits;
  • Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment; or
  • The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the shock wave treatment procedure, standard-of-care self-care requirements, and all study-related follow up visit requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366132

Locations
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, D.C., District of Columbia, United States, 20007
Contact: Rene Laughlin, RN    202-444-7288      
Principal Investigator: Christopher Attinger, MD         
United States, New York
Calvary Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Linda Waltrous    718-518-2149      
Principal Investigator: Oscar Alvarez, Ph.D.,WCA         
United States, Ohio
Akron General Recruiting
Akron, Ohio, United States, 44307
Contact: Dawn Sues, RN    330-344-1122      
Principal Investigator: David Kay, MD         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Matthew Wagener, BS    409-747-5749      
Principal Investigator: Saul Trevino, MD         
Podiatry Group of South Texas Recruiting
San Antonio, Texas, United States, 78229
Contact: Rebecca Reyes    830-981-5150      
Principal Investigator: Richard L Childers, DPM         
Sponsors and Collaborators
Tissue Regeneration Technologies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00366132     History of Changes
Other Study ID Numbers: G050198
Study First Received: August 17, 2006
Last Updated: August 17, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Tissue Regeneration Technologies:
Diabetic
Foot Ulcers
TRT
DermaGold
Shockwave
ESWT
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Diabetic Foot
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetic Neuropathies

ClinicalTrials.gov processed this record on April 15, 2014