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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT01657474 Completed - Diabetic Foot Ulcer Clinical Trials

Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.

NCT ID: NCT01645891 Completed - Diabetic Foot Ulcer Clinical Trials

A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen (CDO) Therapy to Standard Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

Start date: April 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers. The primary objective of this study is to evaluate the effectiveness of CDO in combination with standard moist wound therapy (MWT) on wound healing as compared to standard MWT alone.

NCT ID: NCT01552499 Completed - Diabetic Foot Ulcer Clinical Trials

Comparative Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

Start date: March 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.

NCT ID: NCT01450943 Completed - Diabetic Foot Ulcer Clinical Trials

VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic

DOLCE
Start date: October 1, 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy.

NCT ID: NCT01427569 Completed - Diabetic Foot Ulcer Clinical Trials

Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

Start date: March 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.

NCT ID: NCT01389362 Completed - Diabetic Foot Ulcer Clinical Trials

The Healing Effect of a Two-Herb Recipe on Foot Ulcer in Chinese Patients With Type 2 Diabetes

Start date: May 2009
Phase: Phase 2/Phase 3
Study type: Interventional

There is now a global epidemic of diabetes and obesity affecting more than 300 million people worldwide with Asia in the forefront. In Hong Kong, diabetes affects more than 10% of the population. Patients with diabetes have a 12—25% lifetime risk of developing a foot ulcer.The abnormal metabolic milieus of hyperglycemia, hyperlipidemia, hypertension, pro-thrombotic state and chronic inflammation in diabetes causes atherosclerosis.A significant proportion of subjects have underlying peripheral arterial disease and neuropathy. These subjects are at great risk of developing infective foot ulceration secondary to impaired vascular supply, sensory loss and minor trauma.Without prompt and proper medical treatment, these infective ulcers will deteriorate leading to gangrene and limb amputation. In-vitro and in-vivo studies revealed that 5 out of the 12 herbs were effective in promoting fibroblast proliferation and angiogenesis. To minimize potential drug interactions and adverse effects from multiple components in a recipe of Traditional Chinese Medicine (TCM), the investigators have developed a simplified formula from the 12 herbs consisting of only two herbs. In this proof-of-concept study, the investigators hypothesize that the novel recipe of herbal medicine will expedite healing of early foot ulcer by promoting vascularisation and granulation as well as modulating inflammatory response.

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: NCT01113515 Completed - Diabetic Foot Ulcer Clinical Trials

Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers

Start date: February 20, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

NCT ID: NCT01108120 Completed - Diabetic Foot Ulcer Clinical Trials

The Therapeutical Role of Continuous Intra-femoral Artery Infusion of Urokinase on Diabetic Foot Ulcers

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

- Diabetic foot ulcers (DFU) are one of the chronic consequences of diabetes which constitute the most important cause of non-traumatic amputation of the inferior limbs. Patients with diabetes are 22 times more likely to have foot ulceration or gangrene than nondiabetics,while foot ulceration precedes 85% of lower-extremity amputation. - Three factors combine to promote tissue necrosis in diabetic feet: ischemia, neuropathy and trauma. Among them, ischemia peripheral arterial disease may play the important roles in the development of DFU. Moreover, diffuse vascular disease is the main characteristics, and thus it becomes difficult for treatment by using arterial bypass or balloon angioplasty. Therefore, we hypothesized that continuous arterial thrombolysis may be an effective therapy in diabetic foot. The purpose of this study is to investigate the effectiveness and safety of continuous intra-femoral artery injection of urokinase by micro-artery-pump in diabetic ulcers.