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.