Prospective randomized controlled study of Hydrofiber dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Clinical evaluation of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers. Evaluation of a collagen-alginate wound dressing in the management of diabetic foot ulcers. Use of a hydrocapillary dressing in the management of highly exuding ulcers: a comparative study. Diabetic foot ulcerations. A controlled, randomized comparison of two moist wound healing protocols: Carrasyn Hydrogel Wound dressing and wet-to-moist saline gauze. A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds. A comparison of two dressings in the management of chronic wounds. Combination of hydrocolloid dressing and medical compression stockings versus Unna's boot for the treatment of venous leg ulcers.
Diabetic foot ulcers (DFUs) are at risk of infection and impaired healing, placing patients at risk of lower extremity amputation. DFU care requires debridement and dressings. A prospective, multicentre study compared clinical efficacy and safety of AQUACEL Hydrofiber dressings containing ionic silver (AQAg) with those of Algosteril calcium alginate (CA) dressings in managing out-patients with Type 1 or 2 diabetes mellitus and non-ischaemic Wagner Grade 1 or 2 DFUs.
                Patients stratified by antibiotic use on enrolment were randomly assigned to similar protocols including off-loading, AQAg (n = 67) or CA (n = 67) primary dressings and secondary foam dressings for 8 weeks or until healing. Clinical efficacy measures were healing outcomes and primarily healing speed. Adverse events were recorded.
                AQAg and CA groups were comparable at baseline. All ulcer healing outcomes improved in both groups. The mean time to healing was 53 days for AQAg ulcers and 58 days for CA ulcers (P = 0.34). AQAg-treated ulcers reduced in depth nearly twice as much as CA-treated ulcers (0.25 cm vs. 0.13 cm; P = 0.04). There was more overall ulcer improvement and less deterioration in AQAg subjects (P = 0.058), particularly in the subset initially using antibiotics (P = 0.02). Safety profiles of both groups were similar.
                When added to standard care with appropriate off-loading, AQAg silver dressings were associated with favourable clinical outcomes compared with CA dressings, specifically in ulcer depth reduction and in infected ulcers requiring antibiotic treatment. This study reports the first significant clinical effects of a primary wound dressing containing silver on DFU healing. Nonhealing diabetic foot ulcers are a common cause of amputation. Emerging cellular therapies such as platelet-rich plasma gel provide ulcer management options to avoid loss of limb. The purpose of this prospective, randomized, controlled, blinded, multicenter clinical study was to evaluate the safety and efficacy of autologous platelet-rich plasma gel for the treatment of nonhealing diabetic foot ulcers. One hundred, twenty-nine (129) patients were screened; 72 completed a 7-day screening period and met the study inclusion criteria. Patients were randomized into two groups - the standard care with platelet-rich plasma gel or control (saline gel) dressing group - and evaluated biweekly for 12 weeks or until healing. Healing was confirmed 1 week following closure and monitored for another 11 weeks. An independent audit led to the exclusion of 32 patients from the final per-protocol analysis because of protocol violations and failure to complete treatment. In this group, 13 out of 19 (68.4%) of the platelet-rich plasma gel and nine out of 21 (42.9%) of the control wounds healed. After adjusting for wound size outliers (n = 5), significantly more platelet-rich plasma gel (13 out of 16, 81.3%) than control gel (eight out of 19, 42.1%) treated wounds healed (P = 0.036, Fisher's exact test). Kaplan-Meier time-to-healing also was significantly different between groups (log-rank, P = 0.0177). No treatment-related serious adverse events were reported and bovine thrombin used in the preparation of PRP did not cause Factor V inhibition. When used with good standards of care, the majority of nonhealing diabetic foot ulcers treated with autologous platelet-rich plasma gel can be expected to heal. To evaluate the utility of a semipermeable polymeric membrane dressing for the treatment of chronic diabetic foot ulcers.
                Nineteen subjects with either insulin-dependent diabetes mellitus (IDDM) or non-insulin-dependent diabetes mellitus (NIDDM) and foot ulcers were randomly assigned to the polymeric dressing or conventional wet-to-dry saline dressings. Subjects had foot ulcer site measurements performed every 3 weeks. The subjects using conventional therapy were allowed to cross over to polymeric dressing after 2 months.
                At the end of 2 months, in the patients using the polymeric dressing, ulcer size was reduced to 35 +/- 16% of baseline. The patients on conventional therapy had an ulcer size of 105 +/- 28% of baseline (P < 0.03, polymeric vs. conventional). Patients initially treated with wet-to-dry saline were crossed over into the polymeric membrane treatment and demonstrated a decrease to 35 +/- 11% of baseline size (p < 0.02) after an additional 2 months.
                The semipermeable polymeric membrane dressing is a useful therapeutic option for treating uncomplicated chronic diabetic foot ulcers. Efficacy and safety of a collagen-alginate topical wound dressing (FIBRACOL Collagen-Alginate Wound Dressing) in the treatment of diabetic foot ulcers was compared with that of regular gauze moistened with normal saline. Seventy-five patients with foot ulcers were assigned randomly in a 2:1 ratio to the collagen-alginate test dressing or the gauze dressing. At the end of the study, the mean percent reduction of the wound area was 80.6% +/- 6% in the collagen-alginate dressing group and 61.1% +/- 26% in the gauze dressing group (p = .4692). Thirty-nine (78%) patients treated with the collagen-alginate dressing achieved > or = 75% wound area reduction, compared with 15 (60%) of gauze-treated patients. Complete healing was achieved in 24 (48%) of the collagen-alginate dressing group and 9 (36%) of the gauze dressing group. Wound size, when averaged over the 8-week period and with the duration of the ulcer taken into account, was reduced significantly in the collagen-alginate dressing group, as compared with the gauze dressing group (df = 1, p = .0049). It is concluded that the collagen-alginate test dressing is as or more effective and safe as the currently used treatment. To evaluate the safety and performance of Alione Hydrocapillary dressing (Coloplast A/S) in the management of highly exuding chronic venous leg ulcers and compare it with two hydropolymer dressings,Tielle and Tielle Plus (Johnson & Johnson).
                A comparative clinical trial was conducted on 97 patients with an ankle brachial pressure index > or = 0.8 and a highly exuding leg ulcer. Ulcer duration was at least four weeks. Treatment continued until healing or for a maximum of 12 months.
                There was no statistically significant difference in healing time or wound area reduction between the two treatment protocols. The test dressing (Alione Hydrocapillary) had better absorption capacity and was more comfortable for the patients than the comparator dressings (Tielle/Tielle Plus) and adhered less to the wound bed.Also, more patients preferred the test dressing to their previous treatment. Although severe leakage and maceration were observed more frequently in the comparator group compared with the test group, this was not statistically significant.
                Both treatment protocols were safe and effective in treating highly exuding chronic venous leg ulcers. The test dressing performed as well as or better than the comparator dressings for all study parameters and more patients preferred the test dressing to their previous dressing compared with the comparator dressings. nan Optimal treatment for large diabetic foot wounds is ill defined. The purpose of this study was to compare the rate of wound healing with the Vacuum Assisted Closure device trade mark (VAC) to conventional moist dressings in the treatment of large diabetic foot wounds. Diabetics with significant soft tissue defects of the foot were considered for enrollment. Patients were randomized to receive either moist gauze dressings or VAC treatments for 2 weeks, after which they were treated with the alternative dressing for an additional 2 weeks. Wounds were photographed weekly and wound dimensions calculated in a blinded fashion with spatial analysis software. Percent change in wound dimensions were calculated and compared for each weekly assessment and over 2 weeks of therapy with each dressing type. Ten patients were enrolled in the trial, but two were lost to follow-up and two were withdrawn. Complete data were available for analysis on seven wounds in six patients. Average length, width, and depth of the wounds at initiation of the trial was 7.7, 3.5, and 3.1 cm, respectively. Only the wound depth was significantly decreased over the weeks of the trial to 1.2 cm ( p < 0.05). VAC dressings decreased the wound volume and depth significantly more than moist gauze dressings (59% vs. 0% and 49% vs. 8%, respectively). VAC dressings were associated with a decrease in all wound dimensions while wound length and width increased with moist dressings. In summary, over the first several weeks of therapy, VAC dressings decreased wound depth and volume more effectively than moist gauze dressings. Negative-pressure wound treatment may accelerate closure of large foot wounds in the diabetic patient. A hydropolymer dressing (Tielle) and a hydrocolloid dressing (Granuflex) were compared in a randomised controlled clinical study involving 100 patients with leg ulcers and 99 patients with pressure sores in the community. Statistically significant differences in favour of the hydropolymer dressing were detected for dressing leakage and odour production, but no statistically significant differences were recorded in the number of patients with either leg ulcers or pressure sores who healed in each treatment group. Various therapeutic approaches have been developed to manage venous ulcers. In this study the effectiveness of a hydrocolloid dressing (Comfeel Ulcer Dressing) in comparison to the Unna boot, the prototype of rigid bandages, was evaluated.
                Design: Prospective, comparative study.
                University hospital.
                Sixty patients diagnosed with post-thrombotic chronic venous insufficiency with venous ulcers were randomly assigned to two groups of 30 patients. Interventions: In group A, the Unna boot, and in group B, hydrocolloid dressing in addition to the elastic compression were used. Measures: The two groups were compared in terms of 1) complete healing, 2) weekly wound surface reduction, 3) time to complete healing, 4) performance characteristics (ease-of-use score), 5) pain during application and at home, 6) application time.
                The duration of the ulcers was 16.6 +/- 5.8 weeks in group A and 16.9 +/- 6.2 in group B (p >0.05). Previous ulcer recurrence was 74% (20/27 patients) in group A and 73% (19/26 patients) in group B (p >0.05). The initial ulcer size was 6.38 +/- 1.2 cm2 in group A and 6.19 +/- 0.8 cm2 in group B (p >0.05). The complete healing rates were 74.07% (20/27) in group A and 80. 76% (21/26) in group B (p >0.05). The weekly wound surface reductions were 1.28 +/- 0.72 cm2/week and 1.16 +/- 0.38 cm2/week in groups A and B, respectively (p >0.05). The ulcer healing time was 6.85 +/- 3.60 weeks in group A, whereas it was 6.65 +/- 3.31 weeks in group B (p >0.05). Ease-of-use score was 9.04 +/- 2.38 in group A and 17.27 +/- 3.27 in group B and the difference was significant (p <0.0001). A higher degree of pain was reported by the patients who were treated with the Unna boot, both during application (group A 3.69 +/- 1.35, group B 1.88 +/- 1.48, p <0.0001) and at home (group A, 3.27 +/- 1.08, group B, 1.88 +/- 1.11, p <0.0001). The average time spent on Unna boot changes was 150.59 +/- 34.73 min, compared to 134.54 +/- 43.39 min in group B (p >0.05).
                These results demonstrate the superiority of hydrocolloid dressing plus elastic compression treatment in terms of patient convenience.
There is some evidence to suggest that hydrogel dressings are more effective in healing (lower grade) diabetic foot ulcers than basic wound contact dressings however this finding is uncertain due to risk of bias in the original studies. There is currently no research evidence to suggest that hydrogel is more effective than larval therapy or platelet-derived growth factors in healing diabetic foot ulcers, nor that one brand of hydrogel is more effective than another in ulcer healing. No RCTs comparing hydrogel dressings with other advanced dressing types were found.