Adjuvant PEG Intron in Ulcerated Melanoma
Ulcerated MelanomasPatients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk. The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.
The Regeneration Effects of Derma-PACE Shockwave in Chronic Diabetic Ulcers
Skin UlcerManagement of chronic diabetic foot skin ulcers require multidisciplinary approaches including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in selected cases. The results are inconsistent and irregular, and most studies reported unsatisfactory results. Many adjunctive therapies are implemented in the care of chronic diabetic foot ulcers including hyperbaric oxygen therapy (HBO), ultrasound, recombinant human platelet-derived growth factor-BB (rPDGF-BB), vacuum assisted wound closure (VAWC) and acellular matrix. HBO is the most commonly utilized at the investigators institution. Mixed results of HBO in chronic diabetic foot ulcers are reported. Several studies reported that the beneficial effects of HBO, but none showed universal success. Therefore, the development of a new effective method of treatment for chronic diabetic ulcers is extremely valuable. Extracorporeal shockwave therapy (ESWT) acts as mechanotransduction that produces the therapeutic benefits through complex biological pathways including neovascularization and tissue regeneration. ESWT also showed bacteriostatic effects in experiments. Some studies reported the effectiveness of ESWT in acute and chronic soft tissue wounds. Others reported effectiveness of ESWT in chronic ulcers with 50% completely healed with 6 sessions of treatment. With this background, it appears that ESWT may be effective in the treatment of chronic diabetic foot ulcers. The purpose of this study is to evaluate the efficacy of ESWT in chronic foot ulcers, and to compared with that treated with HBO, and to study the molecular and blood flow perfusion before and after ESWT.
Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept Study
Diabetic Foot UlcerThe aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the healing of complicated diabetic foot ulcers.
Chronic Venous ULcer TReatment Analyzing Bio-Electrical Stimulation Therapy
Chronic Venous Leg UlcersIndication: Subjects with chronic venous leg ulcers Primary Objective: • To evaluate the efficacy of bio-electrical stimulation therapy in the healing of chronic venous leg ulcers Secondary Objective(s): To evaluate the percentage of wound healing every two weeks To evaluate the complete ulcer healing every two weeks To evaluate the time to complete ulcer healing To evaluate the recurrence rate at the end of the follow-up period To evaluate pain To evaluate the quality of life Study Design and Treatment Scheme: This is a Kingfisher Healthcare NV sponsored, national, multicenter, randomized, prospective study in which data will be collected of subjects with chronic venous leg ulcers receiving standardized conventional therapy (SCT). Subjects will be randomized into two groups receiving SCT + placebo or SCT + bio-electrical stimulation therapy (BEST) to evaluate the effect of BEST on the wound healing process. Patients answering the eligibility criteria will receive standardized conventional therapy during 4 weeks before actual study start and will then again be evaluated on eligibility according to wound healing rate. Only patients with a wound surface that has not significantly changed (both increased or decreased) will be randomized in the treatment period. During the treatment period patients will receive SCT with placebo or SCT in combination with bio-electrical stimulation therapy on a daily basis for two hours, during 8 weeks. Patients will be in follow-up period for a maximum of 8 weeks after treatment period.
Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis.
Ulcerative ColitisThe purpose of this study is to evaluate if retarded phosphatidylcholine is as effective as mesalazin in preventing an acute episode in ulcerative colitis. The hypothesis is, that ulcerative colitis is cuased by a defect in the barrier function of the colonic mucus. The background of the study is the finding that the phosphatidylcholine content of the colonic mucus is reduced in patients with ulcerative colitis, in both healthy and inflamed parts of the colon.
Effect of Platelet Concentrate in Treatment of Diabetic Ulcers
DiabetesAutologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds
Safety and Efficacy Study of ICXP007 With Compression Bandaging for the Treatment of Non-Infected...
Leg UlcerThe main purpose of the study is to compare treatment of non-infected venous leg ulcers using ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer compression bandaging and four-layer compression bandaging alone.
Second Line Therapy for the Cure of Helicobacter Pylori (H. Pylori) Infection
Helicobacter InfectionsGastritis2 moreProton pump inhibitors (PPIs) are mainly metabolized in the liver by CYP2C19, one of the cytochrome P450 isoenzymes, which shows a genetic polymorphism associated with enzyme activities. The most essential role of a PPI in H. pylori eradication therapy is to make antibiotics more stable and bioavailable in the stomach by raising intragastric pH to neutral levels. Most patients who have failed in the eradication of H. pylori infection by triple therapy with a PPI, amoxicillin (AMPC) and clarithromycin (CAM) at standard doses have extensive metabolizer (EM) genotypes of CYP2C19 and/or are infected with CAM-resistant strains of H. pylori. Four-times daily dosing of a PPI could achieve complete gastric acid inhibition. Dual therapy with 4-times daily dosing of a PPI and AMPC could yield sufficient re-eradication rates in patients with EM genotype of CYP2C19. Metronidazole (MNZ)-based re-eradication therapy, such as triple PPI/AMPC/MNZ therapy, also achieved high eradication rates and has been recommended as the second line therapy in Japan. But carcinogenic actions of MNZ have been unclear. The purpose of this study is to compare the re-eradication rates of H. pylori infection by the dual high-dose PPI/AMPC therapy and triple PPI/AMPC/MNZ therapy, and to validate the efficacies of these re-eradication regimens as second line eradication therapies.
Wound Healing: Total Contact Cast Vs. Custom-Made Temporary Footwear for Patients With Diabetic...
Neuropathic Foot Ulceration in Individuals With DiabetesObjective: to compare the effectiveness of irremovable total contact casts and custom made temporary footwear to heal neuropathic foot ulcerations in individuals with diabetes
Safety & Efficacy Study for the Use of Extracorporeal Shockwaves in the Treatment of Diabetic Foot...
Chronic Diabetic Foot UlcersThe purpose of this clinical study is to compare the safety and effectiveness of shockwave treatment combined with standard-of-care treatment, to standard-of-care treatment alone to induce healing of a chronic plantar foot ulcer in subjects with diabetes mellitus. For the purpose of this study, the definition of plantar foot ulcer is a wound or open sore that involves the plantar(bottom) aspect of the foot, and the definition of chronic is a duration of 6 weeks or greater with a lack of response to treatment.