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Evaluation of the Effect of Vivostat Platelet Rich Fibrin(PRF) in the Treatment of Diabetic Foot Ulcers

2014-08-27 03:27:02 | BioPortfolio

Summary

Diabetic foot ulcers are a challenge to health care professionals because there are only few effective topical therapeutic interventions.

Growth factor treatment has shown to be beneficial for healing of diabetic foot ulcers in conjunction with extensive surgical debridement. Autologues platelet releasate which contains platelet derived growth factor appears to be more effective than standard therapy in case studies.

This protocol will evaluate the healing effect of Vivostat PRF treatment of non-eschemic foot ulcers to identify responders and to enable sample size calculation for a subsequent pivotal trial.

Study Design

Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Diabetic Foot Ulcers

Intervention

Vivostat PRF

Location

Woundhealing Centre Bispebjerg Hospital
Copenhagen
Denmark
2400

Status

Recruiting

Source

Vivostat

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:27:02-0400

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Medical and Biotech [MESH] Definitions

Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.

Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Devices used to support or align the foot structure, or to prevent or correct foot deformities.

Distortion or disfigurement of the foot, or a part of the foot, acquired through disease or injury after birth.

Entrapment of the distal branches of the posterior TIBIAL NERVE (which divides into the medial plantar, lateral plantar, and calcanial nerves) in the tarsal tunnel, which lies posterior to the internal malleolus and beneath the retinaculum of the flexor muscles of the foot. Symptoms include ankle pain radiating into the foot which tends to be aggravated by walking. Examination may reveal Tinel's sign (radiating pain following nerve percussion) over the tibial nerve at the ankle, weakness and atrophy of the small foot muscles, or loss of sensation in the foot. (From Foot Ankle 1990;11(1):47-52)

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