Randomized Clinical Evaluation of the Healing Activity of Green Propolis Ointment in Individuals with Lower Limb Ulcers Resulting from Leprosy: Preliminary Results of a Pilot Study

Abstract

Background/Objectives: Treating chronic wounds incurs substantial costs for Brazil's Unified Health System. Natural compounds, particularly propolis, are increasingly explored as low-cost alternatives due to their healing properties. Brazilian green propolis, distinct in its chemical composition, has garnered scientific interest. This study aimed to assess the healing effects of green propolis ointment on lower-limb ulcers from leprosy. Methods: A blinded, randomized clinical trial included 18 wounds in two groups: propolis ointment (G1) and control (G2), with evaluations conducted weekly for 61 days. Wound progress was monitored using morphometry and the Pressure Ulcer Scale for Healing (PUSH). Results: No participants exhibited sensitivity to the propolis. G1 showed significant initial healing: average wound area reduction (%) for G1 vs. G2 included 56.38 vs. 6.13-p < 0.001 (week 1); 79.51 vs. 24.16-p = 0.022 (week 4); and 84.33 vs. 39.73-p = 0.051 (week 7). In G1, the PUSH scores decreased from the beginning, whereas in G2, reductions were observed after three weeks. By week 5, 71.4% of G1 wounds scored below eight points, versus 33.3% in G2. G1 wounds exhibited a reduced area and exudate, as well as revitalized granulation tissue without adverse effects. Conclusions: The findings suggest that green propolis ointment is safe, supports tissue repair and may offer cost-effective treatment benefits. Standard wound dressings are selected to support all healing stages, with an emphasis on antimicrobial action, hemostasis to reduce exudate, and pain-reducing and non-irritant properties. Green propolis ointment meets these criteria, offering a cost-effective treatment that accelerates lesion reduction and encouraging leprosy patients to follow the therapeutic regimen.

Keywords: Brazilian green propolis; clinical study; healing; leprosy; ulcer.

Figure 1

Reduction in the wound area (%) during the weeks of treatment. The wound area was measured weekly using the tracing technique, followed by morphometric analysis, allowing detailed monitoring of the evolution of the lesion throughout the treatment. The data reveal a decrease in the wound area in both groups: the group that received propolis (G1) and the control group (G2) throughout the intervention period. It is observed that, in G1, the reduction was significantly more pronounced compared to that in G2 until the sixth week of treatment, with a particularly high percentage of reduction in the first two weeks, indicating a more effective therapeutic response in the initial phase of treatment. NS = no statistical significance. *, significant at the 0.05 level; **, significant at the 0.01 level; ***, significant at the 0.001 level. The exact p-values according to the number of treatment weeks were <0.001 (week 1), 0.002 (week 2), 0.022 (week 3), 0.022 (week 4), 0.014 (week 5), 0.022 (week 6), and 0.051 (week 7).

Figure 2

Morphometry of ulcers. Images (A–C) are wounds belonging to G1 (on the left); (D–F) are wounds belonging to G2 (on the right); The morphometric analysis was performed using the edges of the wounds as a reference to measure the total area. The green dashed lines indicate the edges of the lesions in the initial assessment (A0), while the red dashed lines indicate the edges of the lesions in the final assessment (A8). Macroscopically, a more pronounced reduction in the lesion area is observed in G1 compared to G2. Furthermore, there is an improvement in the revitalization of the affected tissue and adjacent tissues, which contributes to tissue repair. Measuring the area and tissue vitality are components used in the PUSH scale to assess the evolution of the clinical condition.

Figure 3

PUSH scale average (%) during the weeks of treatment. The figure represents the data considering a cut-off of eight points on the PUSH scale. Note that the percentage of high scores (>8) gradually decreased with continued treatment in both groups. Also note that in G1 (propolis ointment), this decrease occurred from the beginning of treatment, while in G2 (control ointment), this reduction began only after the third week of treatment. Also, in week 5, 71.4% of G1 wounds versus 33.3% of G2 wounds were scored at less than eight points (<8). In the final week, 66.7% of G1 wounds versus 50% of G2 wounds presented a low score. The drop in the score reflects the reduction in the dimensions of the lesion (length and width), as well as the reduction in the amount of exudate and the improvement in tissue quality.