Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial.

Objective: Fifty-two subjects with chronic venous insufficiency and hard-to-heal lower leg ulceration (>1-year-old and >20-cm2 surface area) were treated with either intermittent, gradient, pneumatic compression (n = 27) plus standard compression therapy or compression therapy alone (control). Methods: Compression therapy consisted of a nonadherent primary wound dressing plus a 4-layer compression bandage (n = 25). The mean age and size of the ulcers were 1.4 years and 31 cm2, respectively, and did not differ significantly between groups. Intermittent pneumatic compression was performed using a 4-chamber pneumatic leg sleeve and gradient, sequential pump. All pumps were calibrated to a pressure setting of 50 mm Hg on each subject, and treatments were for 1 hour twice daily. Evaluations were performed weekly to measure edema, local pain, granulation, and wound healing. Results: The median time to wound closure by 9 months was 141 days for the intermittent pneumatic compression-treated group and 211 days for the control group (P = .031). The rate of healing was 0.8 ± 0.4 mm/d for the control group and 2.1 ± 0.8 mm/d for the group treated with intermittent pneumatic compression (P < .05). When compared with subjects treated with standard care, the group treated with intermittent pneumatic compression reported less pain at each evaluation point for the first 6 weeks of the trial. At weeks 1, 2, and 3, the visual analog pain scores were significantly lower for the intermittent pneumatic compression-treated group (P < .05). Conclusion: These results suggest that intermittent pneumatic compression is a valuable adjunct to compression therapy in the management of large or painful venous ulcers.

Planimetric Post-hoc Analysis of Women With Onychomycosis from Tavaborole 5% Phase III Studies: Evidence of Greater Improvements in Patients With >50% Baseline Infection.

Women with onychomycosis may suffer more effects on their quality of life than men. There is limited female-specific data on the treatment of onychomycosis. Tavaborole is a topical treatment option for onychomycosis. This post-hoc study evaluated the nail plates of women using data from the tavaborole 5% Phase III studies at baseline and end of study for the areas of healthy nail and infected nail. Over 52 weeks (48-week treatment, 4-week follow up), women treated with tavaborole had an average 32% increase in healthy nail and 21% decrease in infected nail. Patients with baseline infection involving >50% of the nail plate had an average increase in percentage of unaffected nail surface area of 81% and a corresponding 51% decrease in infected nail. These analyses suggest that patients with the greatest toenail involvement at baseline had greater overall improvements than those who were less affected. This evaluation provides additional clinical guidance for treating women with onychomycosis using tavaborole. J Drugs Dermatol. 2018;17(2):168-172.

A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits.

This study focused on a clinically relevant healthcare problem in the military: acute soft tissue wounds, or blisters. The trial was a prospective, controlled, randomized two-arm study evaluating the efficacy of a bioelectric dressing, Procellera®, applied topically two to three times per week for 2 weeks to blisters developed in Ranger trainees during training at Fort Benning, Georgia. A total of 80 US Army Ranger recruits with blister wounds below the knee were randomly assigned to one of two treatment groups (n = 40/group). The primary goal was to assess the clinical efficacy (rate of healing) of administered Procellera in conjunction with the standard-of-care (SOC) treatment, moleskin and Tegaderm ®, on the healing rate of blisters compared with the SOC treatment alone. The secondary end points for efficacy were the quantities of wound fluid biomarkers and bacterial bioburden. The tertiary end point was assessment of pain in the treatment group compared with that of the control group during the 2-week study. The results showed no statistical difference between the SOC and SOC+Procellera groups in wound healing and pain. Wound fluid was reported for 24 participants (64.9%) in the SOC group and 21 participants (56.8%) in SOC+Procellera group at the baseline measurement (ρ = .475); however, the wounds were devoid of fluid on follow-up visits. The mild nature of the wounds in this study was apparent by the low pain scores at the beginning of the study, which disappeared by the follow-up visits. The average wound sizes were 2.2cm2 and 1.5cm2 for the SOC and SOC+Procellera groups, respectively. This trial protocol should be conducted on open softtissue wounds in severe heat. To our knowledge, this is the first clinical study conducted within the US Army Rangers training doctrine.

Effect of High-pressure, Intermittent Pneumatic Compression for the Treatment of Peripheral Arterial Disease and Critical Limb Ischemia in Patients Without a Surgical Option.

UNLABELLED: Thirty-four subjects with symptomatic peripheral arterial disease (PAD) or critical limb ischmeia (CLI) who were experiencing claudication pain, chronic resting pain, numbness, and ischemic lower leg/foot ulceration were randomized into 2 treatment groups. MATERIALS AND METHODS: Eighteen of these patients received treatment with high-pressure, intermittent pneumatic compression (HPIPC) 60 minutes twice daily for 16 weeks, and 16 subjects received standard care consisting of an exercise regimen of walking for 20 minutes twice daily for 16 weeks. The HPIPC device delivers bilateral pressures of 120 mm Hg. Cycle times provide sequential compression for 4 seconds (+/- 0.5 seconds) followed by a 16-second rest period (+/- 3.0 seconds), resulting in a 20-second cycle or 3 cycles per minute. The study was designed to measure patient-centered outcomes. The primary endpoint was peak walking time (PWT), defined as time to maximally tolerated claudication pain. Secondary endpoints included change in resting ankle brachial index, ulcer healing, relief of resting/wound pain, and quality of life (QoL) index. Age (73.7 years vs 72.7 years), baseline PWTs (1-6 minutes), and risk factors were similar in both treatment groups. RESULTS: At 4 weeks, the percent change from baseline in PWT did not vary significantly between treatment groups (17.8% for HPIPC and 17% for standard care). After 8 weeks, the percent change in PWT for the HPIPC group was 41% compared to 32% for the group receiving standard care (P = 0.062). At the 16-week time point the percent change from baseline in PWT was significantly different between treatment arms (35.5% for the standard care group and 54.7% for the group receiving HPIPC [P = 0.043]). The mean reduction in wound surface area was 57% and 71% at 12 weeks and 16 weeks, respectively, for the HPIPC group, compared to 45% and 56% for the control group. The HPIPC group reported significantly greater pain relief at the 12-week (P = 0.044) and 16- week (P = 0.038) time points. Compared to the control group, the HPIPC group reported improvement in patient-centered outcomes such as physical function and bodily pain. These differences were statistically significant (P less than 0.05) at the 16- week evaluation period. CONCLUSION: Therapy consisting of HPIPC for 2 hours daily for a period of 16 weeks significantly improved PWT, reduced resting pain, and improved healing rates, physical function, and bodily pain. There were no devicerelated complications, allowing for long-term use. This study further supports that HPIPC is safe and effective and should be considered for patients who are not candidates for endovascular or surgical procedures. Furthermore, HPIPC offers an excellent alternative for the palliative care of patients with PAD and CLI symptoms.

Wounds measured from digital photographs using photodigital planimetry software: validation and rater reliability.

UNLABELLED:  Traditional wound tracing technique consists of tracing the perimeter of the wound on clear acetate with a fine-tip marker, then placing the tracing on graph paper and counting the grids to calculate the surface area. Standard wound measurement technique for calcu- lating wound surface area (wound tracing) was compared to a new wound measurement method using digital photo-planimetry software ([DPPS], PictZar® Digital Planimetry). METHODS: Two hundred wounds of varying etiologies were measured and traced by experienced exam- iners (raters). Simultaneously, digital photographs were also taken of each wound. The digital photographs were downloaded onto a PC, and using DPPS software, the wounds were measured and traced by the same examiners. Accuracy, intra- and interrater reliability of wound measurements obtained from tracings and from DPPS were studied and compared. Both accuracy and rater variability were directly related to wound size when wounds were measured and traced in the tradi- tional manner. RESULTS: In small (< 4 cm2), regularly shaped (round or oval) wounds, both accuracy and rater reliability was 98% and 95%, respectively. However, in larger, irregularly shaped wounds or wounds with epithelial islands, DPPS was more accurate than traditional mea- suring (3.9% vs. 16.2% [average error]). The mean inter-rater reliabil- ity score was 94% for DPPS and 84% for traditional measuring. The mean intrarater reliability score was 98.3% for DPPS and 89.3% for traditional measuring. In contrast to traditional measurements, DPPS may provide a more objective assessment since it can be done by a technician who is blinded to the treatment plan. Planimetry of digital photographs allows for a closer examination (zoom) of the wound and better visibility of advancing epithelium. CONCLUSION: Measurements of wounds performed on digital photographs using planimetry software were simple and convenient. It was more accurate, more objective, and resulted in better correlation within and between examiners. .