These trials did not provide data on healing or infection, but it appeared that there was no difference in the side effects experienced by participants whose ulcers were treated systemically or topically (moderate certainty evidence). In this situation these are generally the only bacteria against which clinicians need target their antimicrobial therapy. We did not downgrade for unclear 'Risk of bias' assessments in other domains. Group 2: 25/67 participants experienced 1 or more events. The limited and weak available evidence does not allow us to draw firm conclusions on the role of any topical antimicrobial in the treatment or prevention of wound infection in people with foot ulcers and diabetes. Group 1: (n = 40) Routine debridement plus standard careGroup 2: (n = 40) Silver ion dressing plus standard careGroup 1: (n = 180) Treated with normal saline dressingMedian healing time in honey group is 18 days (IQR is 6 to 120), and in the saline group is 29 days (IQR 7 to 120). 1°: mean change in ulcer area at end of treatment; 2°: target ulcer infection rate Information from the sponsor received end of December 2016 stated that the trial is not yet complete but last participant out will be achieved in the next week. In addition to the variation in treatments and types of wounds evaluated, the generally poor reporting of the included studies means that we have limited wound‐related baseline information in terms of the infection status and the severity of wounds.
The trial enrolled its target number of participants, with the last participant completed December 2016. Unclear if ulcers were healed in the same or different participants; for the analysis we have assumed in different participants Group 1: (n = 2) Povidone iodine and metronidazole 1% gel dressingGroup 2: (n = 2) Honey and metronidazole 1% gel dressingHealing was defined as complete epithelialisation either by secondary intention or by split skin graft. Clinically significant resistance very rare Antibacterial action requires at least 2 min contact; may cause stinging and erythema; effect may not persist, and efficacy may be reduced in body fluids; prolonged use may cause metabolic acidosis; stains skin and clothing; possible interaction with starches in dressings Indicated for perioperative skin cleansing and for cleansing and prevention of infection in superficial burns, incisions, and other superficial wounds Vegetative bacteria, viruses, and some spores and fungiNo known systemic toxicity. Group 2: 25/67 participants experienced 1 or more events. Although the presence of neuropathy predisposes to developing the wounds that become infected and may delay infection coming to the attention of the patient, it probably does not affect either infection severity or the approach to treatment. 2013) Tissue samples or deep wound swabs should be obtained (after the wound has been cleansed well with saline) from wounds where soft tissue infection is suspected to help identity causative microorganisms and guide antibiotic treatment. Abbreviations: FDA, US Food and Drug Administration; MRSA, methicillin‐resistant For millennia healers have applied various compounds to infected wounds, some of which (e.g. A Phase I/IIa, Randomized Double Blind, Placebo‐Controlled, Dose Escalating Study to Evaluate the Safety and Tolerability of Topically Applied Bisphosphocin Nu‐3 on Infected Diabetic Ulcers of Subjects With Type I or II Diabetes Mellitus (placebo) Enrolling by invitation only (last verified April 2016)Diabetic foot ulcers; infection localised to area of ulcer and mild.1° outcome: treatment‐related adverse events, safety2°: microbiological activity evaluated by wound assessments, presence of pathogenic bacteria A Phase II, Randomized, Parallel, Double‐blind, Placebo‐controlled Study to Assess Prevention of Infection Using a Topical Gentamicin‐Collagen Sponge in Diabetic Patients With Uninfected Lower Extremity Skin Ulcers (placebo sponge) 1° outcome: uninfected diabetic foot ulcers that remain free of signs/symptoms of infection to end of study 2°: days to wound closure; time to any signs/symptoms of infection; decrease in wound area; pathogen burden in infected wounds David Prior, PhD; Chesapeake Foot and Ankle Center, Pasadena (MD), USAA Phase 3 Randomized, Placebo‐Controlled, Blinded Study to Investigate the Safety and Efficacy of a Topical Gentamicin‐Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With an Infected Foot Ulcer (COACT 1 and 2) (placebo is no sponge) Sponge is adjunctive treatment to systemic antibiotic therapy.1° outcome: per cent of participants with a clinical outcome of clinical cure (resolution of all clinical signs and symptoms of infection) ˜10 days after end of treatment; 2° outcomes: baseline pathogen eradication; re‐infection; time to clinical cure; amputation; ulcer closure Nigel Jones, VP, Global Clinical Operations, Innocoll PharmaceuticalsStudy of the Efficacy of Topical Application of Royal Jelly and Panthenol (PedyPhar® Ointment) on the Diabetic Foot Ulcers, an Open Label, Randomized, Non‐placebo‐controlled Study (active comparator panthenol ointment) Diabetic foot ulcers at any stage after proper surgical treatment (if needed)2°: reduction of infection in ulcer site; local reaction possibly related to study drug Platelet Rich Fibrin in Combination With Topical Antibiotics or Antiseptics in the Treatment of Chronic Wounds ‐ a Prospective, Randomized, Active Controlled, Double Blind Pilot Trial With an Observer‐blinded Control Group (3 platelet rich fibrin arms & 1 active comparator (Acticoat)) People with infected chronic wounds (unclear if diabetic foot)1° outcome: reduction of wound area; 2°: number requiring systemic antimicrobial therapy; C‐reactive protein level; wound volume; occurrence of drug‐resistant bacteria Florian Thalhammer, Medical University of Vienna; 0043140400 ext 44400; Double Blind, Randomized, Placebo Controlled Clinical Trial for the Treatment of Diabetic Foot Ulcers, Using a Nitric Oxide Releasing Patch: PATHON 2°: complete cure of any infection; development of infection during treatment; adverse events A Phase I/II, Open Label, Controlled Study to Evaluate the Safety and Efficacy of AppliGel‐G (Gentamicin Sulfate Topical Gel) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers in Patients With Type 1 and Type 2 Diabetes (comparator oral ciprofloxacin and doxycycline alone) For mild to moderately infected diabetic foot ulcers2°: incidence infection cleared; wound volume and area changeA Randomised, Double‐blind, Dose‐response, Placebo‐controlled, Multicenter, Phase IIA Clinical Study to Evaluate the Efficacy and Safety of Topical Application of G.68.y/EtOH in Patients with Type 1 or Type 2 Diabetes With Infected Foot Ulcers (placebo topical gel) Enrolling patients with infected “grade 2 PEDIS” diabetic foot ulcers2°: maintenance of efficacy; tolerability and safetyTrial to Assess Safety and Efficacy of Topical MBN‐101 (BisEDT ) in Patients With Moderate/ Severe Diabetic Foot Infections (placebo – vehicle‐controlled) Not yet open for participant recruitment (last update March 2016)Part I, participants will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (active to placebo).
Most agents that are used exclusively as topical antibiotics have efficacy against gram‐positive bacteria (e.g. Comparison 3 One topical antimicrobial agent compared with an alternative topical antimicrobial agent, Outcome 2 Resolution of infection: medium term follow‐up. This guideline covers preventing and managing foot problems in children, young people and adults with diabetes. We term this scheme the Consolidated Classification of Skin and Soft Tissue Infections (COCLASSTI).The skin, especially in conjunction with the immediately contiguous subcutaneous tissues, is the largest organ in the body.
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