Efficacy and Safety of the Phytochemical Product Linfadren in the Management of Patients With Persistent Ankle Edema Following Trauma or Surgery: A Randomized Controlled Trial

Abstract

Background: Persistent posttraumatic/postsurgery ankle edema (PPAE) is edema that persists from 2 weeks to 3 months after injury or surgery. PPAE has negative effects on the healing process and quality of life. This study aimed to evaluate the efficacy of a phytochemical product containing diosmin, coumarin, and arbutin (Linfadren) in addition to the conventional treatment, in patients with PPAE. Methods: Between October 2018 and February 2020, 60 outpatients with PPAE (42 with ankle fractures and 18 with ankle sprains) were enrolled and randomized (1:1 ratio) to receive either 6-week conventional treatment plus Linfadren (study group) or conventional treatment alone (control group). Primary outcome was ankle edema as measured by the “figure-of-8-20” method. Secondary outcomes were ankle function measured by the Lower Extremity Functional Scale (LEFS), and patient’s overall perceived treatment efficacy. Tolerability of Linfadren was also evaluated. Assessments were performed at baseline, at end of treatment (6 weeks after baseline), and 3 months after the end of treatment (follow-up). A subgroup analysis was also conducted for the injury type (fracture/sprain) to identify if this factor affected the results of the primary outcome measure. Results: At the end of treatment, the study group had a significantly greater improvement in ankle edema, improved ankle function, and more patients who considered this treatment effective compared with the control group. The measured difference in circumference by the figure-of-8-20 method averaged 4% at 6 weeks and 5% at 3 months. No difference between groups was seen in rescue medication. No adverse events were recorded. Subgroup analysis revealed no significant influence of the injury type on the primary outcome measure. Conclusion: Linfadren in addition to conventional treatment was more effective than conventional treatment alone in patients with PPAE. Level of Evidence: Level I, randomized controlled trial.

Intra-Observer and Inter-Observer Reliability of Ankle Circumference Measurement in Patients with Diabetic Foot: A Prospective Observational Study

“…For instance, Guex et al [20] utilized this technique to assess correlations between ankle circumference, symptoms, and quality of life in lower limb oedema. In a recent randomized clinical trial, Cacchio et al [21] employed this measurement to monitor the progression of oedema reduction in post-traumatic patients treated with diosmin, coumarin, and arbutin compared to conventional treatment. Another randomized clinical trial utilized ankle circumference measurement to compare the effectiveness of compression stockings in preventing lower limb oedema and its association with comfort after three hours of flight [22].…”

Study on the risk factors of postoperative wound complications in patients with ankle fracture

“… 9 However, due to the anatomical characteristics of ankle joint, injury violence, soft tissue swelling, fracture end comminution and wound infection, the operation is more difficult and prone to postoperative wound complications. 10 the data show that the operative complication of ankle fracture is 5%–40%. 11 Among them, wound complications accounted for 1.4%–18.8%, 12 which seriously affected the prognosis of ankle joint operation.…”

“…The surgical restoration of the anatomical position of the ankle joint plays an important role in the recovery of ankle function 9 . However, due to the anatomical characteristics of ankle joint, injury violence, soft tissue swelling, fracture end comminution and wound infection, the operation is more difficult and prone to postoperative wound complications 10 . the data show that the operative complication of ankle fracture is 5%–40% 11 .…”