Clinical Trials

 

* Curaderm Cream: Pressure Sore Comparative Study

Pressure ulcers are common among selected patient populations. Early therapeutic intervention may result in a decrease in the number of ulcers that progress to a later stage. The efficacy of specific skin creams for the treatment and prevention of early stage pressure ulcers has not previously been evaluated. We compared the healing rates of paired, early stage pressure ulcers treated with either Curaderm hp cream, Eucerin, cream, or Sween cream. Those ulcers treated with the Curaderm hp cream demonstrated a 100% cure rate within 14 days. The ulcers treated with either the Eucerin cream or Sween cream had a variable outcome. Some of the ulcers were partially healed while others did not heal or progressed to a later stage. The data suggests that the early use of specific skin creams may be useful as adjunctive therapy in the overall treatment protocol of early stage pressure ulcers.

* Curaderm Cream: Diabetic Foot Ulcer Study

Between 5-10 percent of all diabetics will, at some time in their life have an ulceration of their lower extremities (33 – 35). In those who develop gangrene of the ulcerated lower extremity, the operative mortality can be as high as 25 percent with a significant number of the survivors dying within the first post-operative year (36 – 40). If there was only a 3 percent reduction in the number of amputations through successful medical therapy, approximately 300 lives could be saved. In addition, over 27 million dollars would be saved per 1,000 amputations not performed (33). The indirect health care cost saved would be at least 2 to 3 times this amount. Development of a simple, cost effective therapy that could be utilized by the patient at home could significantly impact on the incidence and progression of lower extremity ulcers in diabetics and, as a result, lower overall medical treatment costs. Previously, we had demonstrated that use of a specific skin cream (Curaderm HP, PhytaTek Laboratories, Inc.) resulted in a rapid resolution of pressure ulcers in a debilitated, elderly population (41). We postulated that a similar healing rate may be seen in a diabetic population with lower extremity ulcers. The healing of chronic, therapy resistant lower extremity diabetic ulcers was accelerated during a 30 day therapy interval. Greater than 50% of patients demonstrated complete resolution of their ulcers. The remaining patients demonstrated between 85 – 90% reduction in ulcer area.

* Phytacare: Wound Healing Study in the Treatment of Diabetic Ulcers

This clinical study was initiated as a result of physician feedback showing wound healing potential from use of an Alginate Hydrogel product FDA 510k approved in 1998. It was designed to test the hypothesis that the Alginate Hydrogel dressing facilitated the healing of diabetic ulcers at a greater rate than the Hydrogel vehicle alone, and that the fragrant botanical base used to impart a pleasant fragrance, might be the source of the perceived positive clinical effect. A 21-patient, 8-week comparative study evaluated the accelerated wound healing potential of the Alginate Hydrogel dressing, the Hydrogel vehicle (placebo control) and becaplermin gel 0.01% (active control) in the treatment of diabetic ulcers. ANOVA was used to analyze wound length, width, depth and global scores for epithelialization and granulation. A primary wound efficacy measure is % epithelialization of the wound. When change from baseline to week 8 for the parameter of global evaluation score for epithelialization was analyzed, the Alginate Hydrogel dressing demonstrated a statistically significant mean difference of –2.571 when compared to the Hydrogel vehicle and a statistically significant mean difference of –2.571 when compared to the becaplermin gel.