IRB Clinical Data on VHT®
Early prototype devices demonstrated 84% closure at 20 weeks.
To validate the data, Vaporox replicated the study in 2019 by recruiting 3 of the top wound care providers in Denver who were treating already chronic wounds. The study achieved nearly identical results at 20 weeks on bigger wounds.
Vaporox will be publishing real world, commercial data with Dr. David Armstrong demonstrating 66% wound closure at 20 weeks (76% at the end of the study). These wounds are significantly larger and have a much lower patient compliance rate than comparable clinical study data.
The VHT-200 underwent IRB testing and has been commercially launched. Both data sets are showing improved treatment efficacy over the earlier studies.
Our 2019 peer-reviewed study can be found in JAPMA.
Clinical Study Overview
Clinical Study Overview
25-month-old DFU, Closed in 12 Weeks
Previous Treatments used over 25 months
- Standard Wound Care
- 60 HBO sessions
- Surgical debridement
- Skin grafts
- 24/7 wound vac
The first photo was at intake for this patient. The provider was able to prevent an amputation, however, the wound had stalled for 8 months and was not responding to treatment. After the addition of VHT®, the wound closed in 12 weeks and 16 VHT® treatments. The only variable that changed was adding VHT®, exemplifying even the most diligent wound care providers can benefit from the VHT® assist. Remarkably, this 70%+ jump in just a few VHT® treatments is typical.
8-month-old DFU, Closed in 11 Weeks
Previous treatments used over 8 months
- Slow progressing heel wound
- 8 months of standard wound care
- Compliant CAM boot offloading
This patient was originally admitted to the hospital where she was told that she would likely need an amputation. The on-call podiatrist accepted her as a patient and made great strides with 8 months of diligent wound care, but the wound was recalcitrant. Fortunately, this provider entered the VHT® IRB study and was able to administer VHT® to this compliant patient. This wound healed in 11 weeks with 19 VHT® treatments.
13-year-old Charcot Foot, Closed in 7.7 weeks
Previous treatments used over 13 years
- Total contact casts
- CROW boots
- Multiple surgeries with amniotic graft applications
This patient has vascular issues but is not a diabetic and had given up hope of healing. She moved to her daughter’s house in preparation for a below-the-knee amputation (BKA). While waiting for surgery scheduling, her new provider started treating with VHT® as a “last ditch” effort. When they saw a 50%+ healing rate between the first and second VHT® treatment, they cancelled the amputation surgery. The wound closed in 10 treatments and the patient is ambulating in a custom Charcot AFO boot and back to work on her family cattle ranch in Montana.