Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients.

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non-healing DFUs. After a 2-week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA-treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA- treated group compared with SOC, 37 days vs 67 days in the SOC group (P = .000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.

Evaluation of Bensal HP for the treatment of diabetic foot ulcers.

BACKGROUND: The extract of oak bark (QRB7) has been used for years as a topical medication with success. QRB7 is the proprietary oak bark extract in Bensal HP. It is indicated as an external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas, and in the treatment of insect bites, burns, and fungal infections. OBJECTIVE: To quantitatively measure the difference in diabetic ulcer size reduction when using Bensal HP versus silver sulfadiazine cream (SSC) for topical treatment as an adjunct to conventional treatment. SETTING: Private office of the primary author. METHODS: Forty diabetic patients with noncellulitic plantar Wagner grade 1 or 2 ulcers and a minimal ankle brachial index of 0.75 were randomly assigned to either the Bensal HP (QRB7) treatment group or SSC control group for 6 weeks of treatment. In addition to either Bensal HP or SSC, all wounds were cultured and treated with debridement at time 0, 2, 4, and 6 weeks and with off-loading. RESULTS: The combined wound diameter of the Bensal HP group decreased 72.5% compared to 54.7% for the SSC group. There was a statistical significance between the decreases in wound sizes after 6 weeks of treatment (P = .016). The Cohen effect size for the Bensal HP group was 2.06 compared with 1.03 for the SSC group. CONCLUSION: In this tightly controlled 6-week study in which no patients were lost to follow-up, Bensal HP seems to be an effective treatment for properly treated diabetic ulcers, outperforming an identical control group whose only difference was SSC as a medication.

Management of diabetic small-fiber neuropathy with combination L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate.

Agents used to treat symptoms of diabetic peripheral neuropathy (DPN) are only palliative, not disease modifying. Although studies of monotherapy with L-methylfolate, methylcobalamin, or pyridoxal 5'-phosphate suggest that each of these bioavailable B vitamins may reverse the pathophysiology and symptoms of DPN, data on the efficacy of this combination therapy are limited. Therefore, we assessed the efficacy of an oral combination of L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate for improving epidermal nerve fiber density (ENFD) in the lower extremity of patients with DPN. Eleven consecutive patients with type 2 diabetes with symptomatic DPN were assessed for ENFD at the calf by means of skin punch biopsy and then placed on twice daily oral-combination L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate. After approximately 6 months of treatment, patients underwent follow-up biopsy. At the end of their treatment, 73% of patients showed an increase in calf ENFD, and 82% of patients experienced both reduced frequency and intensity of paresthesias and/or dysesthesias. This preliminary study suggests that combination L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate increases ENFD in patients with DPN.

Bisphosphonates for the treatment of Charcot neuroarthropathy.

Excess osteoclastic activity is believed to be responsible for the destruction in Charcot neuropathic joint disease. By intervening early in the destructive process, it may be possible to halt the progression toward the devastating bone and joint deformity responsible for morbidity in Charcot feet. This retrospective study evaluated the effects of the bisphosphonate pamidronate on associated signs of Charcot. The 13 study patients (14 infusions) administered pamidronate were compared with 10 control patients who were treated with traditional immobilization methods. Limb temperature and alkaline phosphatase levels were measured as markers of the Charcot process. After pamidronate infusion, limb temperature decreased a mean 2.8 degrees F by 48 hours and 7.4 degrees F by 2 weeks. The alkaline phosphatase levels also decreased an average 53% 2 weeks after infusion. The control group showed no reduction in limb temperature at 48 hours, and had an average limb temperature reduction of 2.3 degrees F at 2 to 3 weeks. This was significantly less than the temperature reduction in the treated group ( P = .008 at 48 hours and P = .001 at 2 weeks). Mean alkaline phosphatase levels declined only 9% in the control group, a significantly smaller decline than in the pamidronate-infusion group ( P = .001). These results suggest that pamidronate may be useful in halting the acute phase of Charcot neuroarthropathy.