Use of topical ketanserin for the treatment of ulcers in leprosy patients. Topical phenytoin suspension and normal saline in the treatment of leprosy trophic ulcers: a randomized, double-blind, comparative study. Comparison of topical phenytoin with normal saline in the treatment of chronic trophic ulcers in leprosy. Simple plantar ulcers treated by below-knee plaster and moulded double-rocker plaster shoe--a comparative study. The influence of dressings on venous ulcer healing--a randomised trial. [Treatment of venous ulcera cruris with dry wound dressings. Phase overlapping use of silver impregnated activated charcoal xerodressing]. Unna's boot vs polyurethane foam dressings for the treatment of venous ulceration. A randomized prospective study. Effectiveness and safety of a nonremovable fiberglass off-bearing cast versus a therapeutic shoe in the treatment of neuropathic foot ulcers: a randomized study.
A comparative study was carried out in which 66 leprosy patients with ulcers were randomly divided in two groups of 33 patients each: Group A (experimental group) was treated with ketanserin gel (2%) and group B with clioquinol cream and/or Lassar paste during a three month period. At the end of the study, when ulcer sizes in the two groups were compared, the group treated with topical ketanserin showed superior results (p < 0.001 using Kolmogorov-Smirnov's test). We conclude that the drug is useful as coadjuavant treatment for healing ulcers in these patients. To evaluate and compare two strengths of topical phenytoin sodium suspension (2% and 4%) with normal saline in the healing of acute trophic ulcers in leprosy patients.
                A prospective, parallel, double-blind, randomized study was conducted in 45 leprosy inpatients with acute trophic ulcers. Patients were randomized to receive 2%, 4% or normal saline dressing on their ulcers once daily for 4 weeks. Efficacy parameters such as a reduction in the surface area of the ulcer, bacterial culture of the ulcer swab, appearance of healthy granulation tissue, cessation of ulcer discharge and overall gradation of clinical healing and safety were assessed at weekly intervals.
                The ulcer area reduction was greater in the 2% and 4% phenytoin groups compared with the normal saline group (p<0.001). Appearance of healthy granulation tissue and cessation of ulcer discharge was also observed earlier in the two phenytoin groups. At the end of 4 weeks, 11 ulcers each had healed completely in both the 2% and 4% phenytoin groups compared with none in the control group. There were no statistical differences between the 2% and 4% phenytoin groups. No side effects were reported by any patient.
                Topical phenytoin appears to be an effective, safe and cheap therapeutic option for the healing of trophic ulcers in leprosy patients. Trophic ulceration, one of the most common complications of leprosy, is disabling, distressing, and demoralizing for the patient.
                The wound healing effects of topical phenytoin powder were compared with those of normal saline in a controlled in-patient study of 100 patients with 110 trophic leprosy ulcers of varying chronicity, over a 4-week study period. Fifty patients were assigned to the topical phenytoin group and 50 to saline therapy group. Ten patients had two ulcers each, and, in these cases, one ulcer was treated with phenytoin and the other with saline.
                Over the 4-week treatment period healthy granulation tissue appeared earlier, and mean percentage of ulcer volume reduction was greater, in the phenytoin group (72.1 +/- 19.9% versus 55.5 +/- 21.6%) compared with the control group.
                This difference was statistically significant at the level of P < 0.001. Phenytoin appears to be a useful agent for the promotion of healing of trophic leprosy ulcers. nan To assess the effect of different dressings on venous ulcer healing.
                A randomised clinical trial.
                Patients were randomised to treatment with one of three dressings: a zinc oxide impregnated bandage, a zinc oxide impregnated stockingette, or an alginate dressing. All patients were treated as outpatients and had compression bandaging with two minimal stretch bandages (Elastocrepe) and a stockingette (Tubigrip) to keep the bandages in place.
                One hundred and thirteen patients (133 ulcerated limbs) with chronic ulceration of the leg due to venous disease alone, and attending Fremantle Hospital Leg Ulcer Clinic, Western Australia were entered into the study. Healing was measured as complete healing of the ulcerated limb or failure of the limb to heal within 9 months.
                There was no significant difference between the three groups in ulcer size, duration, and other parameters compared. Healing was affected significantly by ulcer size and which leg was ulcerated. There was significantly faster healing with the paste bandage.
                The use of a paste bandage significantly improved the healing of chronic venous ulcers when used in combination with compression bandaging, and compared to an alginate dressing and a zinc oxide impregnated stockingette. In a controlled randomized study on 40 patients with venous leg ulcers, monotherapy with a dry wound dressing (silver-impregnated--activated charcoal xerodressing; SIAX) was tested. The xerodressing was applied throughout the entire study and was compared with the conventional phase-adapted therapy using diverse topical modalities, e.g. as granulating ointments, zinc paste. etc. The parameters of wound healing were documented in the two randomized groups over 6 weeks and were statistically evaluated. In the statistical comparison of SIAX therapy (n = 19) and conventional therapy (n = 19) significant differences were found in favour of the SIAX group (increase of epithelialization, reduction of ulcer size; P less than 0.05). In addition, the ulcers of 6/19 patients (= 31.6%) treated with SIAX healed completely within the study period, in contrast to only 2/19 patients (= 10.5%) receiving conventional therapy. Exudate, granulation and colonization of the ulcers as well as odour, necroses, erythema and oedema of the surrounding areas were not significantly different. The study shows that a consistent therapy performed with dry wound dressings such as SIAX is superior to the conventional topical therapy of venous leg ulcers in some cases. Wound dressings provide new therapeutic modalities, being easy to apply and fully efficient, without side-effects. Recent reports have suggested that polyurethane foam dressings provide a more rapid and comfortable healing of venous stasis cutaneous ulcerations than standard semirigid impregnated gauze dressings. This multi-institutional study consists of a randomized, prospective comparison of 36 consecutive patients who were treated with either polyurethane foam dressings (group 1, n = 17) or Unna's boot (group 2, n = 19) for venous ulceration of the lower extremities. Ulcer size ranged from 6.0 to 270 cm2 (mean, 32.2 cm2) for group 1 and 0.2 to 600 cm2 (mean, 76.0 cm2) for group 2. Nine (52.9%) of 17 group 1 patients withdrew from the study due to wound odor, while there was 100% compliance in group 2. Overall wound healing was superior in group 2 (18 [94.7%] of 19) as compared with group 1 (7 [41.2%] of 17) (chi 2 = 8.2). The rate of healing was also better in group 2 (0.5 cm2/d) than in group 1 (0.07 cm2/d). Contrary to published European trials, impregnated gauze dressings exhibited superior treatment results when compared with polyurethane foam dressings in the current study. To evaluate and compare the rate of reduction of the surface area of neuropathic plantar ulcers in diabetic patients treated with nonremovable rigidity-differentiated fiberglass off-bearing casts or a cloth shoe with a rigid sole with unloading alkaform insoles. The secondary aim was to evaluate the side effects and degree of patient acceptance of treatment.
                Fifty diabetic patients with neuropathic plantar ulcers were consecutively enrolled and randomized to one of two treatment groups. Of the 50 patients, 24 were treated with a specialized cloth shoe with a rigid sole and an unloading alkaform insole (shoe group), and 26 patients were treated with a nonremovable off-bearing fiberglass cast (cast group). All patients in both study groups returned to the clinic for weekly control visits. Their ulcers were treated with a standard dressing. Tracings of the ulcer area using a transparent dressing were performed on the day of entry to the study and after 30 days of treatment. The presence of new ulcerations caused by the use of the pressure-relief apparatus was recorded. Patient acceptance of the treatment was measured using a visual analog scale.
                At the end of the treatment period, an 8.3% increase of the ulcer area was observed in two patients in the shoe group, whereas in the cast group, no patient presented an increase. The reduction of the ulcer area was statistically more rapid in the cast group (Mann-Whitney test, P = 0.0004). Furthermore, the number of ulcers completely healed at the 30-day time point was 13 (50%) in the cast group and 5 (20.8%) in the shoe group (P = 0.03). In both groups, no side effects were recorded. The average score +/- SD of patient acceptance was 91.15 +/- 9.9 in the shoe group and 88.33 +/- 17.3 (NS) in the cast group.
                Our study has shown a significant difference in the speed of the reduction of neuropathic plantar ulcers treated with a fiberglass cast compared with a specialized cloth shoe. The use of fiberglass material with variable rigidity has also shown two important results: the elimination of side effects including ulcers caused by the cast, and high patient acceptance. These data show that the use of off-bearing casts made with fiberglass bandages of variable rigidity is the elective treatment of neuropathic plantar ulcers.
One study suggested that topical ketanserin is more effective than clioquinol cream or zinc paste. Topical phenytoin (two studies) may be more effective than saline dressing regarding ulcer healing. For the other dressings the results were equivocal. Canvas shoes were a little better than PVC-boots, but not significantly, and the effect of double rocker shoes compared to below-knee plasters was no different in promoting the healing of ulcers. No side effects were documented.
There is a lack of high quality research in the field of ulcer prevention and treatment in leprosy. New trials should follow the current standards for design and reporting of randomised controlled trials.