Cath Lab Digest

David G. Armstrong, DPM, MD, PhD
Professor of Surgery and Director
Southern Arizona Limb Salvage Alliance (SALSA)
University of Arizona College of Medicine

  As we know, an amputation is performed every 30 seconds around the world due to diabetes. We are facing a demographic tsunami of diabetes and wounds over the coming generation. Modalities (and data) such as the following results are very exciting potential tools to stem the tide. Derma Sciences Inc (Princeton, NJ) has announced positive results from its Phase 2 clinical trial with DSC127 in patients with diabetic foot ulcers, including meeting the trial's primary endpoint— the proportion of study ulcers healed by 12 weeks as defined by 100% epithelialized with no drainage, as well as all secondary endpoints measured at this time. DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon injury to tissue. The double-blind, placebo-controlled, multi-center clinical trial randomized a total of 80 patients to receive one of two dose strengths of DSC127 (0.03% and 0.01%) or vehicle placebo control. After 14 days of best standard-of-care to evaluate ulcer healing and ensure the wounds were chronic, those patients randomized into the study received 4 weeks of active treatment followed by 8 weeks of observation and assessment. In the Intent-to-Treat (ITT) population results show that 54% of the diabetic wounds treated with the 0.03% dose (ie, the high dose) of DSC127 achieved 100% closure in 12 weeks or less, compared with 33% of patients receiving placebo control, and 30% of patients receiving the 0.01% dose (ie, the low dose) of DSC127.

  Based on odds ratio analysis, patients treated with DSC127 0.03% were 2.3 times more likely to have their wounds heal completely compared with patients treated with placebo/standard of care. In the Per-Protocol (PP) population results conveyed that 65% of the diabetic wounds treated with the 0.03% dose of DSC127 achieved 100% closure in 12 weeks or less, as compared with 38% of patients receiving placebo control, and 28% of patients receiving the 0.01% dose of DSC127. Based on odds ratio analysis, patients treated with DSC127 0.03% were 3.0 times more likely to have their wounds heal completely compared with patients treated with placebo/standard of care. The high dose of DSC127 exceeded the trial's primary endpoint measurement target of an improvement of 15 percentage points in complete healing of wounds within the 12-week duration of the study for both the ITT (21 percentage point increase) and PP (27 percentage point increase) populations, compared with placebo. The trial was not powered for statistical significance, however there was a statistically significant (P = 0.049) improvement in the rate of ulcer depth reduction in the PP high-dose population through 12 weeks of treatment compared with the control arm, using covariate analysis.

  As the study’s lead investigator, I found that the clinical results from this trial are promising, as application of 0.03% DSC127 appears to increase healing rates at a level greater than has been previously reported by drugs currently on the market and in development. Although further testing in a pivotal study is required, it seems that DSC127 at this point has potential to be an important therapy for the treatment of diabetic wounds.

  Executive Officer, Edward J. Quilty, noted that results from this Phase 2 trial exceeded the company’s expectations and Derma Sciences was delighted to be reporting such compelling results. The next step in the development process is to discuss these results with the FDA in an end-of-Phase 2 meeting, and to advance development into Phase 3. These results are transformational for the company as they look forward to sharing the data with potential development and commercial partners, and in due course, DSC127 will be brought to market to alleviate the suffering of millions of patients with these debilitating and stubborn wounds.

For more information, visit www.dermasciences.com.

To learn more about SALSA or to contact Dr. Armstrong, please visit
http://DiabeticFootOnline.com/ or http://ToeandFlow.com/.