| Methods |
RCT; two arm parallel group; open label. |
| Participants |
80 participants; inpatient and outpatient.
Inclusion criteria: Presence of clinical signs of venous ulceration (e.g. hyperpigmentation, lipodermatosclerosis, varicosities, oedema), absence of arterial insufficiency (ABI>0.85), evidence of venous insufficiency (venous refilling time determined by PPG<25 seconds).
Exclusion criteria: Hypersensitivity to methylxanthines, PTX, caffeinated or cola drinks, systemic treatment with corticosteroids, cytotoxics, rutosides, anticoagulant or fibrinolytic agents with the previous 2 months, clinically significant medical conditions that would impair wound healing (renal, hepatic, haematologic, neurologic, and immunologic diseases), diabetes, infected ulcer, pregnancy or lactation, presence of ulcer for < 2 months, ulcer size < 0.75cm2.
Mean age: Gp1. 61.5 years, Gp2. 61.2 years.
Mean ulcer duration: not reported.
Mean ulcer size: Gp1. 5.1cm2, Gp2. 5.4cm2
Mean ABI: inadequate data presented. |
| Interventions |
Group 1 (n=40): PTX 400mg tds + hydrocolloid dressing.
Group 2 (n=40): hydrocolloid dressing.
Treatment duration: 24 weeks |
| Outcomes |
Complete healing: Gp1. 23/40 (58%), Gp2. 11/40 (28%).
Side effects: Gp1. 11/40, Gp2. 0/40.
Withdrawals: (n=14), Gp1. 5/40 (13%), Gp2. 9/40 (23%).
Reasons: Side effects (Gp1. 3/40, Gp2. 0/40), infections (Gp1. 0/40, Gp2. 3/40), other medications commenced (Gp1. 1/40, Gp2. 3/40), Other (Gp1. 1/40. Gp2. 3/40) |
| Notes |
If more than one ulcer, largest ulcer selected as reference ulcer. A priori sample size calculation. Patients were recommended compression, but refused for various reasons, including costs of bandages, discomfort whilst wearing bandages, itching, difficulties in applying bandages, and personal conviction ulcers would not heal when compressed. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Quote: "The study used a prospective, randomized, open, parallel group, comparative design ...".
Comment: Baseline table equivalent, but method for achieving randomisation not reported. |
| Allocation concealment (selection bias) |
Unclear risk |
Comment: Not reported. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Quote: "The study used a prospective, randomized, open, parallel group, comparative design ...".
Comment: Open label trial, so unblinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Quote: "Fourteen patients were withdrawn from the trial, but they were included in the analysis as failure to heal on treatment". |
