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

Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb...
Arterial Occlusive DiseasePeripheral Vascular Disease2 moreThe objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing, reduction in amputation, improved pain at rest and hemodynamic measurement and to assess the effectiveness of the administrative method.

Treatment of Cutaneous Ulcers With a Novel Biological Dressing
Venous UlcersThe aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.

Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis....
ColitisUlcerativeThe purpose of this study is to test the long-term safety and tolerability of SPD476 in the maintenance of ulcerative colitis remission.

A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination...
Stomach UlcerThe purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.

Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)
Spinal Cord InjuryPressure UlcersPressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Epidemiological studies have found that 36-50% of all persons with SCI who develop pressure ulcers will develop a recurrence within the first year after initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al., 1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database, NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997). Although little data exist describing the factors associated with recurrence following surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative complications and 6% to 61% in cases without post-operative complications (Mandrekas & Mastorakos, 1992; Relander & Palmer, 1988; Disa et al., 1992). In a retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et al., 1999).

Study for the Treatment of Ulcerative Colitis With Adacolumn
Ulcerative ColitisThe purpose of this study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis
Ulcerative ColitisGastrointestinal Disease1 moreThe purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.

Achilles Tendon Lengthening in Patients With Diabetes to Prevent Foot Ulcers
Diabetes MellitusFoot Ulcer1 morePeople with diabetes often develop severe skin problems (ulcers) on their feet. Sometimes these are treated with surgery and other times by temporarily immobilizing the foot in a cast. This study compares the effect of surgery to lengthen the Achilles tendon and put the foot in a cast, to using a cast alone. The study will also examine how foot strength, joint movement, and overall ability to walk, balance and climb stairs is affected.

Value of Pharmacokinetic Assays in the Prediction of Therapeutic Response in Ulcerative Colitis...
Ulcerative ColitisVedolizumab (VDZ) is a monoclonal antibody that binds to the heterodimer α4β7 integrin and which has shown its efficacy in Ulcerative Colitis (UC) by inducing and maintaining clinical response/remission. The French marketing authorization was obtained for Ulcerative Colitis in patients in failure with anti-Tumor Necrosis Factor (anti-TNF) agents. In the pivotal study, correlation between drug levels and clinical response during induction and maintenance therapy were reported. Moreover, in 3.7% of cases, anti-vedolizumab antibodies were reported during the time-course and 1% had samples that were persistently positive. Up to now, data on the pharmacologic VDZ parameters are scarce and the relationships as well as the predictive value of the measurement of VDZ concentrations and VDZ monoclonal antibodies (mAbs) during the induction and maintenance phases remains unknown. It could be of paramount interest to early identify UC patients under VDZ who will be responders to VDZ induction and to identify those who will achieve clinical remission under maintenance therapy with VDZ.