None listed
Conditions
Brief summary
The aim of this prospective, pragmatic, parallel-group randomized active-controlled trial was to evaluate the effectiveness and safety of oral administration of a supplement drug (Linfadren®) containing diosmin, coumarin and arbutin in addition to conventional treatment, in patients with post-trauma/surgery persistent ankle edema. A total of 60 outpatients (mean age 47.7 ± 9.26 years) with post-trauma/surgery persistent ankle edema were enrolled. Patients were randomized to either receive six-week conventional treatment plus Linfadren® (Study Group) or conventional treatment (Control Group). Primary outcome was ankle edema as measured by figure-of-eight-20 method. Secondary outcomes were ankle function, patient’s overall perceived treatment effectiveness and rescue medication request. Tolerability of Linfadren® was also evaluated. Assessments were performed at baseline, at the end of treatment and three months after the end of treatment. Our hypothesis is that the use of Linfadren® associated with conventional treatment is more effective than conventional treatment alone in management of patients with post-trauma/surgery persistent ankle edema.
Interventions
Once eligible for the trial, participants will be recruited and randomised into one of the following 6-week interventions:
1) conventional rehabilitation treatment (control group)
2) conventional rehabilitation treatment plus Linfadren® (study group)
a) conventional rehabilitation treatment consisting of elevation, cryotherapy, low-compression garments, retrograde massage, and gentle hand movement. These treatments were performed once a day for five days a week for six weeks, Patients will rece
Once eligible for the trial, participants will be recruited and randomised into one of the following 6-week interventions: 1) conventional rehabilitation treatment (control group) 2) conventional rehabilitation treatment plus Linfadren® (study group) a) conventional rehabilitation treatment consisting of elevation, cryotherapy, low-compression garments, retrograde massage, and gentle hand movement. These treatments were performed once a day for five days a week for six weeks, Patients will receive sessions with retrograde massage and gentle ankle movement on a one-to-one basis with an experienced physiotherapist who also monitored the patients' adherence to the other treatments b) Linfadren® is a marketed supplement formulation which contains 200 mg of diosmin, 30.6 mg of coumarin, and 3.7 mg of arbutin. Coumarin (alpha-benzopyrones), stimulating macrophage activation and proteolysis, favors the reduction of excess stagnant proteins from tissues, with a decrease of edema and chronic inflammation. Diosmin (gamma-benzopyrones) is mainly a vascular-protecting agent, improving venous tone, protecting capillary bed microcirculation, reducing capillary permeability, but being potent inhibitors of inflammatory mediators as prostaglandin E2 (PGE2) and thromboxane A2 (TxA2), also exhibits anti-inflammatory properties. Arbutin is a natural product found in different plants including bearberry (Arctostaphylos uva-ursi) and has diuretic properties that help to reduce water tissue retention. Patients were instructed to consume one oral capsule of Linfadren® on an empty stomach twice a day (6-hourly: 11a.m. and 5 p.m.) for two weeks, and once a day for four weeks. The dose asministered at each interval (one capsule) contains 200 mg of diosmin, 30.6 mg of coumarin, and 3.7 mg of arbutin. To improve adherence as far as medication assumption we asked patients to self-compile a daily diary.
Sponsors
University of L'Aquila
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria were: 18 years or older, diagnosis of post-trauma/surgery persistent ankle edema with a difference greater than or equal to 20 mm between the affected ankle and the unaffected ankle as measured by figure-of-eight-20 method. Persistent edema was an edema that persisted for more than two weeks.
Exclusion criteria
Exclusion criteria were: bilateral ankle edema; pulmonary edema; congestive heart failure; coagulation defects; any contraindications limiting clinical evaluation and therapy of the patient.
Outcome results
None listed