ABSTRACT – The DFU healing rate produced by “the standard of care” (debridement + gauze) is 30.9%. In a clinical trial, doctors determined that the addition of VHT to the standard of care increased this to 90.7%. The group of patients in this trial were chosen specifically because they had wounds that had defied conventional treatment, and most were facing amputation.
The VHT-100 is 510(k) cleared by the FDA. In order to demonstrate safety and efficacy of the product to the scientific community and healthcare payers, Vaporox (then named IYIA Technologies, and subsequently Cure Care) conducted a controlled clinical trial of VHT therapy using the VHT-100 on diabetic foot ulcer wounds with the comparator being the standard of wound care.
The protocol was reviewed and approved by the Western Investigational Review Board for ethical and human subject protection considerations prior to commencement of the trial.
Subjects eligible for the study were aged 18 and older, of both genders, with chronic diabetic, arterial and venous foot ulcers (University of Texas Health Science Center classification as Wagner Grade 2-4).
The data on the standard of wound care was taken from a meta-analysis of randomized controlled trials. The meta analysis included studies of uninfected diabetic neuropathic foot ulcers with adequate perfusion.
The analysis estimated the weighted mean percentage of wounds health by 12 weeks and 20 weeks. Ten controls from these studies were used to estimate the effectiveness of standard care, which included debridement, avoidance of weight bearing, and either saline-moistened gauze or placebo gel and gauze.
Grouped-data logistic regression was used to assess the impact of patient age, wound size (area), and wound duration on the percentage healed.
The trial included 31 patients with a total of 38 ulcers. All wounds had failed to heal with standard therapy, which consisted of debridement, avoidance of weight bearing, and moistened gauze.
Twenty-three (23) of the patients had 29 diabetic neuropathic ulcers; 21 were males and 2 were females with an average age of 61. Of the 29 neuropathic ulcers, 19 were grade 2, six (6) were grade 3, and four (4) were reported as grade 3.5 by the University of Texas Health Science Center classification system. These wounds averaged 1181 mm3 in size and 24 months in duration.
The comparison of the VHT-100 results to the standard-of-care results showed a significant improvement in neuropathic wound healing with VHT-100. The proportions of healed wounds were about 200% better at 12 and 20 weeks: 24% compared to 74% and 31% compared to 87%.
This is such a substantial improvement that even with a relatively small number of VHT-100 patients, the comparisons were highly statistically significant.
Of special interest is the fact that the VHT-100 wounds were healed after having failed standard wound care. This means that if VHT-100 were used the same way in real-world situations, one might expect 31 patients out of 100 to heal with standard care, and 87% of the remaining 69 patients, or 60 additional patients, to heal with VHT-100.
This strategy would heal a total of 91 of 100 patients.
In both studies, the wounds were diabetic neuropathic wounds, and the standard- of-care described in the meta-analysis was essentially the same therapy that the VHT-100 patients received along with the new treatment. The control wounds were likely to have received the best available non-investigational care, as they were enrolled in randomized control trials.