Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot Ulcers
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ClinicalTrials.gov Identifier: NCT00366132 |
Recruitment Status : Unknown
Verified August 2006 by Tissue Regeneration Technologies.
Recruitment status was: Recruiting
First Posted : August 18, 2006
Last Update Posted : August 18, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Diabetic Foot Ulcers | Device: Extracorporeal Shockwaves | Phase 2 |

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 |

- Time to Complete Wound Healing
- 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")

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366132
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 |
ClinicalTrials.gov Identifier: | NCT00366132 |
Other Study ID Numbers: |
G050198 |
First Posted: | August 18, 2006 Key Record Dates |
Last Update Posted: | August 18, 2006 |
Last Verified: | August 2006 |
Diabetic Foot Ulcers TRT DermaGold |
Shockwave ESWT Diabetes Mellitus |
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 |