Pentoxifylline--efficient in the treatment of venous ulcers in the absence of compression? Randomised, double blind placebo controlled trial of pentoxifylline in the treatment of venous leg ulcers. Pentoxifylline in the treatment of venous leg ulcers. Systemic treatment of venous leg ulcers with high doses of pentoxifylline: efficacy in a randomized, placebo-controlled trial. A factorial, randomized trial of pentoxifylline or placebo, four-layer or single-layer compression, and knitted viscose or hydrocolloid dressings for venous ulcers. Treatment of venous ulcers with pentoxifylline: a 6-month randomized, double-blind, placebo controlled trial. An evaluation of Hyalofill-F plus compression bandaging in the treatment of chronic venous ulcers. Beneficial hemorheologic therapy of chronic peripheral arterial disorders with pentoxifylline: results of double-blind study versus vasodilator-nylidrin. A randomized, double-blind, placebo-controlled trial of pentoxifylline for the treatment of recurrent aphthous stomatitis.
The aim of the study was to test the efficacy and tolerability of pentoxifylline on the healing of venous ulcers in the absence of standard limb compression. The study used a prospective randomized, open, controlled, comparative, parallel group design. The study included 80 eligible patients with confirmed venous ulcers (with clinical and photoplethysmography findings). The patients received either pentoxifylline 1200 mg per day (3 x 400 mg) orally in addition of local therapy, or the same local therapy alone. The main outcome measures were complete healing of ulcers, change in the ulcer area over the six-month observation period, and tolerability of the drug. The results showed that complete healing occurred in 23 (57.5%) patients receiving pentoxifylline and 11 (27.5%) patients without pentoxifylline (log rank test =2.49, p=0.013). Unwanted effects of pentoxifylline occurred in 11/40 (27.5%) patients but were mild. Pentoxifylline is concluded to be efficacious in healing of venous ulcers in patients unable to tolerate compression therapy. To determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers.
                Randomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.
                Leg ulcer clinics of a teaching and a district general hospital in southern Scotland.
                200 patients with confirmed venous ulcers and in whom other major causal factors were excluded. Interventions: Pentoxifylline 400 mg three times daily or placebo.
                Complete healing (full epithelialisation) of all ulcers on the trial leg.
                Complete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.
                The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance. A double-blind, placebo-controlled study was carried out in 12 patients suffering from chronic venous insufficiency and persistent leg ulcers to assess the efficacy of pentoxifylline treatment as an adjunct to compression bandaging in the conservative management of venous leg ulcers. Six patients were allocated at random to receive twice-daily infusions of 200 mg pentoxifylline intravenously and 400 mg pentoxifylline orally 3-times daily for 7 days then 400 mg oral doses 3-times daily for a further 60 days. The control group received matching placebo in an identical regimen. Treatment outcome was assessed by changes between the start and end of the study in venous ulcer surface area, and continuous wave Doppler ultrasound was used to monitor ankle/arm systolic pressure ratio, venous pressure at the ankle, valvular competence and possible venous reflux at intervals throughout the study period. The results showed that in the patients treated with pentoxifylline complete ulcer healing took place in 4 out of 6 and there was a significant reduction in mean ulcer surface area. In the control group, complete ulcer healing was recorded in 1 out of 6 patient only and the ulcer area was only moderately reduced in the others. There was no statistically significant differences between the two groups in the variables monitored by Doppler ultrasound but the difference between treatment outcome was significant. Treatment was well-tolerated. Several small studies have indicated that the systemic administration of pentoxifylline may accelerate healing of venous leg ulcers. The goal of this study was to further evaluate these findings in a larger scale placebo controlled trial and to explore the effect of the dose of pentoxifylline on healing. The study used a prospective, randomized, double-blind, parallel group placebo controlled design in a multicenter outpatient setting. Patients with one or more venous ulcer were enrolled, with all patients receiving standardized compression bandaging for treatment for their ulcers. Patients were also randomized to receive either pentoxifylline 400 mg, pentoxifylline 800 mg (two 400 mg tablets), or placebo tablets three times a day for up to 24 weeks. The main outcome measure was time to complete healing of all leg ulcers, using life table analysis. The study was completed as planned in 131 patients. Patients receiving 800 mg three times a day of pentoxifylline healed faster than placebo (p = 0.043, Wilcoxon test). The median time to complete healing was 100, 83, and 71 days for placebo, pentoxifylline 400 mg, and pentoxifylline 800 mg three times a day, respectively. Over half of all patients were ulcer free at week 16 (placebo) and at week 12 in both pentoxifylline groups. Whereas the placebo group had only achieved complete healing in half of the cases by week 16, all of the subjects remaining in the group receiving the high dose of pentoxifylline had healed completely. Treatment with pentoxifylline was well tolerated with similar drop-out rates in all three treatment groups. Complete wound closure occurred at least 4 weeks earlier in the majority of patients treated with pentoxifylline by comparison to placebo. A higher dose of pentoxifylline (800 mg three times a day) was more effective than the lower dose. We conclude that pentoxifylline is effective in accelerating healing of leg ulcers. We evaluated the effectiveness of pentoxifylline, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandaging for venous ulceration.
                A factorial randomized controlled trial with 24-week follow-up was conducted in leg ulcer clinics in Scotland with blinded allocation to pentoxifylline (1200 mg) or placebo, knitted viscose or hydrocolloid dressings, and single-layer or four-layer bandages. The study enrolled 245 adults with venous ulcers. The main outcome measure was time to complete healing. Secondary outcomes included proportions healed, withdrawals, and adverse events. Analysis was by intention to treat.
                There was no evidence of interaction between the drug, bandages, and dressings. Pentoxifylline was associated with nonsignificant increased ulcer healing (62% vs 53%; P = .21). Four-layer bandages were associated with significantly higher healing rates (67% vs 49%; P = .009). There was no difference in healing between knitted viscose and hydrocolloid dressings (58% and 57%; P = .88). Cox regression models increased the significance of the pentoxifylline effect (relative risk of healing, 1.4; 95% confidence interval, 1.0 to 2.0).
                Pentoxifylline increased the proportion healing compared with placebo to the same extent as shown in recent systematic reviews, although this finding was only statistically significant when a secondary adjusted analysis was conducted. Four-layer bandaging produced higher healing rates than single-layer bandaging. There was no difference in time to healing between knitted viscose and hydrocolloid dressings. The aim of this study was the evaluation of treatment with pentoxifylline in patients with venous ulcers in a 6-month, randomized, controlled trial. Treatment with placebo or pentoxifylline (PXF; 400 mg, 3 times daily) lasted 6 months and was associated to elastic bandaging. The endpoints were the number of limbs with complete healing and the variation in the area of ulceration. A group of 172 patients were included: 82 in the PXF group and 88 in the placebo group; 82 completed the study in the PXF group and 78 in the placebo group. Results. The two groups were comparable for age and sex distribution. The treatment was well tolerated. Complete healing was obtained in 67% of patients in the PXF group and 30.7% in the placebo group (p<0.02). The variations in the average area of ulceration were 86.7% (decrease) in the PXF group and 47% in the placebo group. The cost of treatment increased 21% with PXF but the cost due to non-healing of the ulcer was equivalent to a 44% increase (in comparison with the PXF group). In conclusion PXF is effective and cost-effective in improving ulcer healing in patients with chronic venous hypertension. Hyaluronan, a component of the extracellular matrix, plays a significant role in several aspects of tissue repair and the wound healing process.
                In this Italian study Hyalofill-F, a partial benzyl ester derivative of hyaluronan, used in combination with compression bandaging, was compared with the well-established therapy in Italy of non-adherent gauze plus compression therapy in the treatment of chronic venous leg ulcers.
                Hyalofill-F plus compression bandaging performed significantly better than non-adherent gauze plus compression bandage in all of the clinically relevant efficacy parameters. Mean reduction in ulcer area in the hyaluronan-derivative group was 8.1 cm2 after eight weeks of treatment, compared with 0.4 cm2 in the comparator group. The resulting difference of 7.7 cm2 between the two groups was statistically significant (p = 0.0019). Furthermore, statistically significant results in favour of the hyaluronan-derivative group were obtained in the following: speed of epithelialisation; leveling of the margins; degree of maceration; pain intensity and frequency.
                Hyalofill-F plus compression bandaging resulted in an earlier and greater decrease in ulcer area compared with non-adherent gauze plus compression bandaging, therapy supporting its use in the treatment of chronic venous ulcers. Pentoxifylline (Trental 400 mg coated tablets) and nylidrin HCl 3 mg were compared for clinical efficacy and safety in an 8-week randomized double-blind trial. The study was conducted in patients with peripheral arterial disease (Fontaine stage II or III), with 30 patients receiving pentoxifylline (23 returned for follow-up), and 30 patients receiving nylidrin HCl (24 returned for follow-up). Efficacy was assessed objectively in terms of walking performance (absolute walking time and walking distance on a treadmill ergometer) and by acral plethysmography. The clear improvement shown for both variables was greater and statistically significant (p less than or equal to 0.05) after treatment with pentoxifylline. Laboratory data provided no evidence to suggest any adverse effect of either treatment. Subjective side effects were reported by six patients in the pentoxifylline group and by three patients in the nylidrin HCl group. To evaluate pentoxifylline for the treatment of recurrent aphthous stomatitis.
                A 60-day, randomized, double-blind, placebo-controlled trial with a 60-day no treatment follow-up.
                An oral medicine specialist referral center in Manchester.
                Forty-nine volunteers who passed the initial assessment for recurrent aphthous stomatitis entered a pretrial phase in which their eligibility for the trial phase of the study was assessed. Sixteen subjects were deemed ineligible, and 7 failed to attend or withdrew. The remaining 26 subjects were randomized to placebo or treatment. Six subjects withdrew because of adverse effects, and 1 was unavailable for follow-up.
                Pentoxifylline (also called oxpentifylline), 400 mg 3 times daily, or matching placebo.
                A reduction in the median pain score, ulcer size, number of ulcers, or total number of ulcer episodes.
                Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline. Patients taking placebo reported no improvement in these variables. Patients taking pentoxifylline also reported more ulcer-free days than those taking placebo. However, the differences were small and, with the exception of median ulcer size (P = .05), did not reach statistical significance. Adverse effects were common with pentoxifylline, but not significantly different from those experienced by patients taking placebo.
                Although pentoxifylline may have some benefit in the treatment of recurrent aphthous stomatitis, the benefit is limited. It may have a role in the treatment of patients unresponsive to other treatments, but cannot yet be recommended as a first-line treatment.
Pentoxifylline is an effective adjunct to compression bandaging for treating venous ulcers and may be effective in the absence of compression. The majority of adverse effects were gastrointestinal disturbances.