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.
Study Drugs:Test Drug: DPOCL
Active-Control drug : Isotonic normal saline 0.9%
Duration: 10 weeks
Objective:Primary- to observe percent reduction in the wound area
Secondary- to calculate the time required to achieve complete wound closure and the total wound evaluation.
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.
Safety: One minor adverse event was noted in the entire duration of the trial in the "Test arm". This was itching on both lower limbs that spontaneously resolved without any treatment.
No adverse event was noted at the wound site. Thus, AE was not associated with the study drugs.
Analysis: Safety profile of the test was comparable with the control.
Both the treatments were found tolerable in the patient population.
Conclusion: The Test drug DPOCL was significantly effective in the treatment of neuropathic, chronic, cutaneous ulcers of the lower extremity in patients with diabetes.
The efficacy of the test drug DPOCL was significantly superior to the active control drug (NaCl) in terms of percent reduction in mean wound surface area (p<0.05)
All the patients, who received DPOCL in the phase II trial healed completely as compared to active-control.
The safety of DPOCL was comparable with "Active-control - [NaCl]" as no adverse events were noted.
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:
Efficacy ParametersPrimary efficacy parameters: Percentage of patients achieving complete wound closure
Secondary efficacy parameters: Time taken for achieving complete wound closure from the onset of wound and the percentage reduction in the wound surface area at each visit.
Any subject who has received at least one application of study drugs will be evaluated from point of safety.
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].
Adverse events: During the trial, total six AEs were recorded following the administration of investigational product, which was irrespective of the nature of the treatment administered [test or active control].
Four out of 6 AEs did happen in the test arm and two out of 6 AEs did happen in the active-control arm.
Conclusion: The preclinical and clinical trial data has proventhat DPOCL is effective and safe in the treatment of diabetic foot ulcer in terms of two most important treatment goals of DFU treatment i.e. complete wound closure and infection control.
Excellent safety of WOXheal® is proved due to lack of AE/ SAE during clinical trials.
Due to no drug to drug or drug to lab interactions, DPOCL can be safely co-prescribed/ with oral hypoglycemic agents or any other concurrent medications.
DPOCL is non-irritating. No allergic, hypersensitive or photosensitive reactions were observed over the entire treatment period.
Unlike other growth factors used in therapy, DPOCL did not cause overgrowth while achieving complete wound closure.