Healthpoint Initiates Randomized, Double-Blind Study To Evaluate Effectiveness Of Collagenase SANTYL® Ointment On Healing Of Diabetic Foot Ulcers

Main Category: Diabetes
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 11 Aug 2010 - 2:00 PDT

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Healthpoint announced that it has initiated a clinical trial assessing the effectiveness of Collagenase SANTYL® Ointment, as compared to vehicle, on the change from baseline in wound area of diabetic foot ulcers (DFU) over four weeks. The trial will also follow subjects to determine the proportion that achieve complete wound closure within 12 weeks of initiating treatment. One of the long-term complications of diabetes is the development of foot ulcers primarily as a consequence of peripheral neuropathy due to prolonged serum glucose elevation.

"Foot ulcers are one of the leading causes of hospitalization for all patients with diabetes and present the most common risk for subsequent amputation among diabetics," noted Vickie Driver, MS, DPM, FACFAS, Director, Clinical Research Foot Care, Endovascular and Vascular Services at Boston University Medical Center and one of ten investigators participating in the study. "This study will help inform the clinical community as to whether a widely prescribed enzymatic debriding agent can have a positive impact on wound closure, thereby avoiding the often devastating sequalae associated with this common condition."

The study is a randomized, double-blind, parallel-group, placebo-controlled trial involving 100 patients undergoing treatment at one of 10 wound care centers in the United States. The study objective is to evaluate daily use of SANTYL® Ointment for the first four weeks of therapy for its ability to initiate a healing cascade by determining the wound closure rate at 12 weeks after the start of treatment. Subjects eligible for enrollment in the study will have an uninfected DFU that has failed to significantly improve after wound treatment for at least four weeks (i.e., less than or equal to 40% closure). Upon enrollment, subjects will be randomized to receive four weeks of treatment with either SANTYL® Ointment or petrolatum (vehicle). During both the 4 weeks of SANTYL® Ointment and the 8 weeks of follow-up, the target ulcers will be covered with a non-adhesive contact layer and a foam dressing.

"The study design combines two concepts: the first being that wound healing can be predicted on the basis of wound area reduction during the first four weeks of any therapy," commented Bert Slade, MD, FAAAAI, Chief Medical Officer at Healthpoint. "The second concept is that four weeks of SANTYL® Ointment will be sufficient to promote healing during a full 12 weeks of moist wound therapy."

About Collagenase SANTYL® Ointment

Collagenase SANTYL® Ointment is a selective enzymatic debriding agent that contains 250 collagenase units per gram of white petrolatum USP. It is indicated for debriding chronic dermal ulcers (e.g., pressure ulcers, vascular ulcers and diabetic ulcers) and severely burned areas. The enzyme collagenase is derived from the fermentation by Clostridium histolyticum and possesses the ability to liquefy collagen in necrotic tissue. Collagenase SANTYL® Ointment is now the most widely used brand of enzymatic debrider in the United States.

Occasional slight transient erythema has been noted in surrounding tissue when applied outside the wound. One case of systemic hypersensitivity has been reported after 1 year of treatment with collagenase and cortisone.

SANTYL, SURGICEPT, ULTRACEPT, THE WOUND INSTITUTE and THEWOUNDINSTITUTE.COM are registered trademarks of Healthpoint, Ltd.

OutLast is a trademark of Healthpoint, Ltd.

OASIS is a registered trademark of Cook Biotech, Inc.

HYDROFERA BLUE is a registered trademark of Hydrofera, LLC.

Source: Healthpoint, Ltd

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