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

Status unconfirmed · Phase 2

Conditions studied: Chronic Diabetic Foot Ulcers

In brief

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.

Key facts

Study ID

NCT00366132

Run by

Tissue Regeneration Technologies

People needed

200

Starts

2006-03-01

Last updated by the study team

2006-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• 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.

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Calvary Hospital — The Bronx, New York, United States (enrolling)
• Akron General — Akron, Ohio, United States (enrolling)
• University of Texas Medical Branch — Galveston, Texas, United States (enrolling)
• Podiatry Group of South Texas — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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