Recruiting

Phase 2

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

Sponsor:

Tissue Regeneration Technologies

Code:

NCT00366132

Conditions

Chronic Diabetic Foot Ulcers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Extracorporeal Shockwaves

Study Details

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.

Conditions

Chronic Diabetic Foot Ulcers

Study ID

NCT00366132

Start date

Mar, 2006

Status verified date

Aug, 2006

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Extracorporeal Shockwaves

Primary outcome measure

Time to Complete Wound Healing [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Georgetown University Hospital

Recruiting

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

Contacts

Rene Laughlin, RN

202-444-7288

Principal Investigator:

Christopher Attinger, MD

Calvary Hospital

Recruiting

Bronx, New York, United States, 10461

Contacts

Linda Waltrous

718-518-2149

Principal Investigator:

Oscar Alvarez, Ph.D.,WCA

Akron General

Recruiting

Akron, Ohio, United States, 44307

Contacts

Dawn Sues, RN

330-344-1122

Principal Investigator:

David Kay, MD

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Matthew Wagener, BS

409-747-5749

Principal Investigator:

Saul Trevino, MD

Podiatry Group of South Texas

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Rebecca Reyes

830-981-5150

Principal Investigator:

Richard L Childers, DPM

More Information

Sponsor

Tissue Regeneration Technologies

Last update posted

Aug 18, 2006

Last verified

Aug, 2006

Keywords

Diabetic
Foot Ulcers
TRT
DermaGold
Shockwave
ESWT
Diabetes Mellitus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tissue Regeneration Technologies on 2006-08-18.