Written by Chrystal Moulton, Staff Writer. In the treatment group, 15 patients had 100% ulcer recovery after 4 weeks versus 4 patients in the placebo group (p<0.001).
Diabetes mellitus is a metabolic disorder associated with vascular complications such as peripheral neuropathy, cardiovascular disease, blindness, and diabetic foot ulcer 1. Diabetic foot ulcers have been identified as an independent predictor of mortality 2 and the leading cause of lower extremity amputation 3. Furthermore, due to the oxidative nature of diabetes, wound healing is slow 4. Teucrium polium, which grows in the Mediterranean region, contains various anti-inflammatory, anti-diabetic, and antioxidant properties 5. However, its efficacy and tolerability have not been evaluated in diabetes patients. In the current trial, investigators researched the tolerability and efficacy of Teucrium polium in diabetic patients with foot ulcers 1.
In a randomized double-blind placebo-controlled study, researchers investigated the healing effects of Teucrium polium on diabetic foot ulcers in participants diagnosed with type 1 or 2 diabetes mellitus. Eligible participants had to be between 20-60 years old with no history of addiction and other chronic illnesses. Participants also needed to have a grade 1 or 2 foot ulcer (based on the Wagner scale 6) located on the forefoot. Ulcer size had to be greater than or equal to 1cm2 and less than or equal to 7cm2 with a depth ≤ 5mm. The wound could not have exposed bones, capsules or tendons, tunneling, nor undermining or sinus tracts. In both groups, patients received routine wound care (daily) and a podiatrist visit every other week. Patients were instructed to clean their wound with saline and moistened gauzes, debride wound as needed, apply ointment twice daily and dress with sterile gauze. Patients were randomly assigned to receive either treatment (98g of Eucerin mixed with 2g of T. polium dissolved in 3mL isopropyl alcohol) or placebo (98g Eucerin). In the test ointment, total flavonoid content (expressed as rutin/g) was 19.92mg rutin/g. Total phenol content (expressed as gallic acid equivalent) was 23.60mg/g. Wound healing was measured through computer-based imaging and the planimetry method, which measured the surface area of the wound. Wound healing status was measured at baseline and end of trial (4 weeks). Patients self-reported any possible adverse events following application of the ointment, which were assessed by physicians as possible interactions specific to the assigned ointment. Total trial period was 4 weeks.
Seventy participants were randomized to either placebo (n= 35) or treatment (n= 35). However, 29 participants in the treatment group and 26 participants in the placebo group completed the trial. At the end of 4 weeks, patients in the T. polium group had significant improvement in their wound status. Based on computer-based imaging, participants in the treatment group had an average 78.2% recovery of ulcer area versus 47.2% in the placebo group. The difference between computer-based imaging in the treatment versus placebo was statistically significant (p<0.0001). According to the planimetry method, the ulcer size was also significantly reduced from baseline in the T. polium group compared to placebo (p<0.0001) [See Table below]. In the treatment group, 15 patients had 100% ulcer recovery after 4 weeks versus 4 patients in the placebo group (p<0.001).
Table 1. Results from baseline to week 4 in study outcomes
Groups | Placebo Baseline | Treatment Baseline | Placebo End of Trial | Treatment End of trial | P- Value |
---|---|---|---|---|---|
Planimetry Method | 3.21 ± 1.67 cm 2 | 3.52 ± 1.47 | 1.63 ± .72 | .717 ± .19 | p<0.0001 |
Computer Imaging | 21,255 ± 12,043 pixels | 23,042 ± 11,707 pixels | 11,225 ± 2,790 pixels | 5,027 ± 3,124 pixels | p<0.0001 |
Treatment with T. polium versus placebo for 4 weeks significantly improved wound healing in patients presenting with diabetic foot ulcers. Evidence in the trial is promising, however, a large-scale placebo controlled clinical study is needed to verify these findings.
Source: Fallah Huseini, Hasan, Maryam Yaghoobi, Farhad Fallahi, Farzaneh Boroumand, Mohammad Hassan Ezzati, Seyyed Mohammad Tabatabaei, Homa Sotvan, Maryam Ahvazi, Shapour Badiee Aval, and Mojtaba Ziaee. “Topical Administration of Teucrium polium on Diabetic Foot Ulcers Accelerates Healing: A Placebo-Controlled Randomized Clinical Study.” The International Journal of Lower Extremity Wounds (2021): 15347346211048371.
© The Author(s) 2021 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/15347346211048371 journals.sagepub.com/home/ijl
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Posted January 28, 2022.
Chrystal Moulton BA, PMP, is a 2008 graduate of the University of Illinois at Chicago. She graduated with a bachelor’s in psychology with a focus on premedical studies and is a licensed project manager. She currently resides in Indianapolis, IN.
References.
- Fallah Huseini H, Yaghoobi M, Fallahi F, et al. Topical Administration of Teucrium polium on Diabetic Foot Ulcers Accelerates Healing: A Placebo-Controlled Randomized Clinical Study. Int J Low Extrem Wounds. Nov 1 2021:15347346211048371. doi:10.1177/15347346211048371
- Iversen MM, Tell GS, Riise T, et al. History of foot ulcer increases mortality among individuals with diabetes: ten-year follow-up of the Nord-Trøndelag Health Study, Norway. Diabetes Care. Dec 2009;32(12):2193-9. doi:10.2337/dc09-0651
- Afkhamizadeh M, Aboutorabi R, Ravari H, et al. Topical propolis improves wound healing in patients with diabetic foot ulcer: a randomized controlled trial. Nat Prod Res. Sep 2018;32(17):2096-2099. doi:10.1080/14786419.2017.1363755
- Li S, Wang C, Wang B, et al. Efficacy of low-level light therapy for treatment of diabetic foot ulcer: A systematic review and meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. Sep 2018;143:215-224. doi:10.1016/j.diabres.2018.07.014
- Stanković M. Teucrium Species: Biology and Applications. Springer, Cham; 2020:XVII, 435.
- Amit Kumar C Jain SJ. Diabetic Foot Classifications: Review of Literature. 2013. Diabetic Foot Classifications.