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Foot Ulcer clinical trials

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NCT ID: NCT01235260 Completed - Diabetes Mellitus Clinical Trials

Becaplermin Use and Cancer Risk in a Patient Population of U.S. Veterans With Diabetes

Start date: March 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.

NCT ID: NCT01228526 Completed - Clinical trials for Foot Ulcers, Diabetic

A Multicenter, Prospective, Observational Study With PriMatrix for the Treatment of Neuropathic Diabetic Foot Ulcers

Start date: August 2010
Phase: N/A
Study type: Observational

To evaluate the effectiveness of PriMatrix in the treatment of DFUs in subjects without significantly compromised arterial circulation.

NCT ID: NCT01221207 Completed - Clinical trials for Diabetic Foot Ulcers

Instant Total Contact Cast to Heal Diabetic Foot Ulcers

ITCC
Start date: October 2010
Phase: N/A
Study type: Interventional

Aim 1. To compare the effectiveness of total contact casts (TCC), removable cast walkers (RCW) and instant total contact casts (ITCC) to heal diabetic foot ulcers in a 20 week randomized clinical trial of 225 patients in community care in three university medical center diabetes clinics. Aim 2. To compare the frequency of complications such as soft tissue and bone infections, iatrogenic wounds, falls and fall related injuries, and amputations among patients treated with TCC, ITCC and RCW to heal diabetic foot ulcers. Aim 3. To compare patient compliance and level of activity among TCC, ITCC, RCW treatment groups. Using computerized activity monitors which time-stamp each step, we will evaluate both degree and magnitude of activity between groups. Aim 4. To evaluate the cost of diabetic foot ulcer-related treatment and complications during the course of therapy.

NCT ID: NCT01221194 Completed - Diabetes Clinical Trials

Therapeutic Stockings to Prevent Foot Ulcers

Start date: October 2010
Phase: N/A
Study type: Interventional

1. To evaluate the efficacy of a therapeutic stockings (Protective Foot Care stockings, PFC) in reducing the incidence of diabetic foot pathology among high-risk patients. 2. To evaluate perceived health-related quality of life as compared to guideline directed usual care in patients who use the PFC stockings.

NCT ID: NCT01217476 Completed - Clinical trials for Diabetic Foot Ulcer of Neuropathic Origin

The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Northern Europe The TRANS-North Study

TRANS-North
Start date: December 2010
Phase: Phase 3
Study type: Interventional

Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product. We conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after a maximum of 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 40 investigational sites in Europe.

NCT ID: NCT01217463 Completed - Clinical trials for Diabetic Foot Ulcer of Neuropathic Origin

The TRAfermin in Neuropathic Diabetic Foot Ulcer Study - Southern Europe The TRANS-South Study

TRANS-South
Start date: November 2010
Phase: Phase 3
Study type: Interventional

Trafermin is a recombinant human basic fibroblast growth factor (bFGF; original development code, KCB-1), which is manufactured by genetic engineering using Escherichia coli by Kaken Pharmaceutical Co., Ltd. (Tokyo, Japan). Trafermin 0.01% cutaneous spray product kit consisting of a glass bottle containing lyophilized trafermin, a glass bottle with solvent for solution and a spray part to fit the glass bottle after reconstitution of the final product. The investigators conduct a multinational, randomized, double-blind, placebo controlled, parallel-group, multicentre study consisting of a placebo run-in phase (2w), a treatment phase (max. 12w) and a follow-up phase (3mo+6mo). The primary objective of the study is to demonstrate a superior wound closure rate of diabetic foot ulcers (DFUs) of neuropathic origin after 12 weeks topical daily application of trafermin 0.01% spray compared with placebo, in addition to best local care (off-loading, dressings). Approximately 210 patients will be randomized and it is planned that this study will be conducted at approximately 30 investigational sites in an estimated 4 countries in Europe (Czech Republic,France,Hungary,Italy,).

NCT ID: NCT01181453 Completed - Diabetic Foot Ulcer Clinical Trials

Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers

Start date: December 1998
Phase: Phase 3
Study type: Interventional

This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.

NCT ID: NCT01181440 Completed - Diabetic Foot Ulcer Clinical Trials

Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

Start date: September 1994
Phase: Phase 3
Study type: Interventional

This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.

NCT ID: NCT01154374 Completed - Clinical trials for Diabetic Foot Ulcers

A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

NCT ID: NCT01143727 Completed - Clinical trials for Diabetic Foot Ulcers

Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

Start date: July 2010
Phase: Phase 4
Study type: Interventional

This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.