Combination Therapy
A German study 1 published in the journal Plastic and Reconstructive Surgery concludes that combining Integra, a skin substitute, with fibrin glue and negative pressure wound therapy can improve clinical outcomes in patients with large acute or chronic wounds.
In the study, 12 patients underwent grafting for wound reconstruction with Integra (Johnson & Johnson, Hamburg, Germany). Six were randomized to the control group (Integra only) and 6 were randomized to the new treatment group (Integra plus fibrin glue and negative pressure wound therapy). The purpose of the study was to determine if new treatment would improve the graft take rate and integration of Integra.
The authors found that the take rate was 20% higher (98 +/- 2 %) in the new treatment group. The mean period from Integra coverage to skin transplant was 14 days less in the new treatment group (24 +/- 3 days in the control group vs 10 +/- 1 days in the new treatment group), resulting in shorter hospital stays and less risk of complications such as infection, thrombosis, and catabolism.
Reference1. Jeschke MG, Rose C, Angele P, Fuchtmeier B, Nerlich MN, Bolder U. Development of new reconstructive techniques: use of Integra in combination with fibrin glue and negative-pressure therapy for reconstruction of acute and chronic wounds. Plast Reconstr Surg 2004; 113(2):525-30. [Context Link]
Diabetic Foot Ulcers
A study to assess the safety of Telbermin applied topically to chronic, diabetic foot ulcers and to explore the possible effectiveness of this treatment to induce healing of diabetic foot ulcers, is currently recruiting patients. Eligibility criteria include age 18 to 80 years; single, full-thickness ulcer of the foot that does not involve bone, tendons, ligaments, or muscle below the malleolus; and a chronic ulcer with a duration of more than 4 weeks but less than 6 months. Sponsored by Genentech, Inc, San Francisco, CA, the randomized, double blind study is placebo-controlled.
King Pharmaceuticals, Inc, Bristol, TN, has completed initial Phase 1 clinical trial dosing of an investigational drug for the topical treatment of chronic diabetic neuropathic foot ulcers. MRE0094 is an adenosine A2A receptor agonist designed to concentrate on the inflammation associated with this type of foot ulcers.
Adenosine A2A receptor agonists have been shown to promote wound closure in mice and diabetes-induced rats by regulating the response of inflammatory cells and mediators. This promotes tissue formation through various mechanisms, including endothelial cell proliferation and migration, which promotes tissue remodeling.
The company plans to begin a Phase 2 clinical trial program involving the drug next year.