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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT00477022 Completed - Diabetic Foot Ulcer Clinical Trials

The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers

VCT
Start date: February 2006
Phase: N/A
Study type: Interventional

the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri’s principle in diabetic patients.

NCT ID: NCT00434538 Terminated - Diabetic Foot Ulcer Clinical Trials

BST-DERMON Versus Standard of Care in the Treatment of Diabetic Foot Ulcers

Start date: February 2007
Phase: Phase 3
Study type: Interventional

This trial is designed to investigate the therapeutic benefits of using BST-DermOn for the wound repair of diabetic neuropathic foot ulcers. The objective of this study is to evaluate the safety and efficacy of BST-DermOn in providing a clinically significant advantage over the standard of care in the repair of diabetic foot ulcers.

NCT ID: NCT00393510 Completed - Diabetic Foot Ulcer Clinical Trials

Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers

Start date: November 2000
Phase: Phase 2
Study type: Interventional

Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. On the other hand, an infected ulcer that never heals just unnecessarily prolongs suffering. Nevertheless, patients earnestly like to try all methods of healing before accepting amputation. Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.

NCT ID: NCT00389636 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Start date: September 2006
Phase: N/A
Study type: Interventional

Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.

NCT ID: NCT00387101 Terminated - Diabetic Foot Ulcer Clinical Trials

Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers

Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.

NCT ID: NCT00368693 Terminated - Diabetic Foot Ulcer Clinical Trials

Efficacy and Safety Study of Dermal-Living Skin Replacement to Treat Diabetic Foot Ulcers

Start date: August 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the efficacy and side effects, if any, of Dermal - LSR combined with standard treatment. We hypothesize the treatment will provide beneficial results for diabetic patients suffering foot ulcers.

NCT ID: NCT00338923 Completed - Diabetic Foot Ulcer Clinical Trials

Wound Healing Effects of HO/03/03 In Patients With Diabetic Neuropathic Plantar and Venous Ulcers, Pilot Study.

Start date: June 2006
Phase: Phase 1
Study type: Interventional

This is a multicenter pilot study to assess the healing effects of HO/03/03 on diabetic neuropathic plantar and venous ulcers. HO/03/03 action mechanism involves the manipulation of keratinocyte and fibroblast migration and differentiation at the wound area. - The primary end point of this study is assessment of safety in treating with HO/03/03 and the efficacy of the drug to promote wound closure of chronic wounds. - The secondary end points are assessment time to closure and healing rate for the measurement of wound healing progression.

NCT ID: NCT00338702 Withdrawn - Diabetic Foot Ulcer Clinical Trials

A Randomized, Controlled Trial of Autologous Platelet Gel Treatment in Diabetic Foot Ulcers

Start date: March 2008
Phase: Phase 4
Study type: Interventional

Foot ulcers represent a significant common complication in patients with diabetes. Wound healing is a challenge. Some wounds do not respond to the best practices in wound care. Considerable effort has been directed at therapies to improve the rate of healing. There are a variety of growth factors which have been used to stimulate wound healing. Human platelets are an autologous source of growth factors which probably can stimulate healing. Autologous platelet gel (APG) is prepared by centrifugation of autologous human whole blood. APG is rich in platelet growth factors. This study will investigate the potential improvement in wound healing with this material in diabetic foot ulcers. This study will compare the use of autologous platelet gel ( study group) and standard care ( control group) in the treatment of diabetic plantar forefoot ulcers. This study will also compare the cost and quality of life in the two groups. Objectives of the study: - To determine if topical APG (autologous platelet gel) is beneficial in the treatment of diabetic foot ulcers. - To determine if it will result in a faster rate of wound healing. - To determine if it will improve the quality of life in patients with diabetic foot ulcers.

NCT ID: NCT00289497 Completed - Diabetes Clinical Trials

TempTouch IR Thermometry & Diabetic Patient Self-Care

Start date: June 2000
Phase: Phase 2/Phase 3
Study type: Interventional

Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops. Areas about to ulcerate become inflamed and “hot spots” can be identified. This study’s purpose is to evaluate the effectiveness of a home infrared temperature probe designed to forewarn patients that an area on the foot is inflamed so they can take preventive measures. The study will evaluate the incidence of diabetic foot ulcers among high-risk patients, evaluate the cost of home temperature monitoring compared to standard therapy, and evaluate patient satisfaction. 180 diabetics at high-risk of having foot complications will be randomized into 3 treatment arms: 1) standard therapy consisting of regular foot care; 2) standard therapy plus recording of a structured foot evaluation using a hand mirror; and 3) standard therapy plus infrared home temperature assessment to identify “hot spots.” Device patients will measure temperatures at 6 sites on the foot each day. When temperatures are elevated >4°F patients will contact the research nurse and decrease activity. The primary study outcome will be incident foot ulcers and Charcot fractures.