WOXheal® - Phase II trial
In this multi-centre, randomized, parallel group, active-controlled clinical trial [2008-09], the efficacy of WOXheal® was examined. It was conducted at 4 centers including AIIMS, Kochi, LTMG, Sion, KEM Hospital, Parel, and Talwalkar Polyclinic, Matunga.
Duration: 10 weeks
Safety variables:Regular safety evaluations, such as vital signs and hematological, biochemical parameters and adverse events were conducted & compared.
Type of Ulcers:
Cutaneous (neuropathic) ulcer ranging in size between 1 and 15 cm [longest single dimension], present for at least 4 weeks were included as classified as per Wagner’s scale Grade 1 and 2 in patients with diabetic mellitus.
Application schedule - Once Every day
There was 72.45% wound reduction with DPOCL vs 60.40% wound reduction with active control.
WOXheal® - Phase III trial
In phase III clinical trial, the efficacy and safety of DPOCL topical solution was investigated in over 280 patients in Eastern, Sourthen, Western and Northern India. In patients suffering from diabetic foot ulcer, WOXheal® solution was compared with active-control solution i.e. isotonic normal saline (0.9 %). From the study, following results were obtained:
Any subject who has received at least one application of study drugs will be evaluated from point of safety.
Figure 9: The percentage of patients with complete wound closure in WOX heal and active-control group.
Figure 10: The number of days for complete closure of the wound in DPOCL and control groups.
Figure 11: The percentage of wounds healed at each visit in active- control and test groups.
1. Complete wound healing: 71.03 % wound completely healed in DPOCL topical solution group as compared to 57.53% healing in the active control. This figure was statistically significant [p=0.0156].
2. Time taken for complete closure of wounds: DPOCL topical solution resulted in faster wound healing compared to active-control. The median time taken for complete closure of wounds in DPOCL topical solution group was 42 days as compared to 56 days in active control group.
3. Overall treatment responders: More than 90% of the patient treated with DPOCL had positive response compared to 66% of active-control [treatment response defined by at least 50% wound reduction in 4 weeks].
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