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

• ClinicalTrials.gov Identifier: NCT00366132
• Recruitment Status: Unknown
• First Posted: August 18, 2006
• Last Update Posted: August 18, 2006
• Sponsor: Tissue Regeneration Technologies
• Information provided by: Tissue Regeneration Technologies

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Diabetic Foot Ulcers	Device: Extracorporeal Shockwaves	Phase 2

  Show Detailed Description

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: DermaGold Indicated for Use of Shockwave Treat of Diabetic Foot Ulcers in Patients With Diabetes Mellitus
• Study Start Date: March 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Time to Complete Wound Healing

Secondary Outcome Measures :

1. o A comparison of the total number of subjects with a final status of “Healed” in the active versus control group
2. o Partial healing at 12 weeks post treatment ((size of wound compared to baseline));
3. 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);
4. o The percentage of the wound that has healed
5. o The number of shock wave treatments performed
6. o Durability of wound closure (i.e., status of wound at one week following determination of “healed”)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• ClinicalTrials.gov Identifier: NCT00366132 History of Changes
• Other Study ID Numbers: G050198
• First Posted: August 18, 2006
• Last Update Posted: August 18, 2006
• Last Verified: August 2006

Keywords provided by Tissue Regeneration Technologies:

Diabetic; Foot Ulcers; TRT; DermaGold; Shockwave; ESWT; Diabetes Mellitus

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases