A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers
Summary
The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Diabetic Foot Ulcers
Intervention
Santyl, White Petrolatum
Status
Not yet recruiting
Source
Healthpoint
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01143714
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:12:55-0400
Clinical Trials
Use of Santyl Within an Accountable Care Organization
This study is designed to assess the comparative effectiveness of SANTYL® versus standard of care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of care...
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
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 a...
Hyperbaric Oxygen Therapy and Angiogenesis in Diabetic Patients With Foot Ulcers
Diabetic foot ulcers are a major cause of morbidity and mortality, accounting for approximately two-thirds of all non-traumatic amputations performed in the United States. The cost of foot...
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers. Patients participating in the study may receive an activ...
Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.
PubMed Articles
Growth factors in the pathogenesis of diabetic foot ulcers.
Foot ulcers affect 15% of patients with diabetes, resulting in a great health burden. The occurrence and development of diabetic foot ulcers is associated with neuropathy, peripheral arterial disease,...
Diabetic foot ulcers are serious and challenging wounds associated with high risk of infection and lower-limb amputation. Ulcers are deemed neuroischaemic if peripheral neuropathy and peripheral arter...
Management of chronic diabetic foot ulcers using platelet-rich plasma.
Platelet-rich plasma (PRP) has been proposed as an adjunct for the treatment of foot ulcers in patients with diabetes, as well as a treatment for chronic and acute wounds. This study examined the appl...
Mechanical stress is important in causing and healing plantar diabetic foot ulcers, but almost always studied as peak pressure only. Measuring cumulative plantar tissue stress combines plantar pressur...
Despite major treatment advances, diabetic foot ulcers (DFUs) remain a frequent and debilitating complication of diabetes mellitus and a major cause of significant morbidity and mortality.
Medical and Biotech [MESH] Definitions
Diabetic Foot
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.
Diabetic Neuropathies
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)
Foot Orthoses
Devices used to support or align the foot structure, or to prevent or correct foot deformities.
Foot Deformities, Acquired
Distortion or disfigurement of the foot, or a part of the foot, acquired through disease or injury after birth.
Petrolatum
A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.
