Randomised controlled trial of the use of three dressing preparations in the management of chronic ulceration of the foot in diabetes.

OBJECTIVES: To determine the comparative effectiveness and cost-effectiveness of three dressing products, N-A, Inadine and Aquacel, for patients with diabetic foot ulcers, as well as the feasibility and consequences of less frequent dressing changes by health-care professionals. DESIGN: A multicentre, prospective, observer-blinded, parallel group, randomised controlled trial, with three arms. SETTING: Established expert multidisciplinary clinics for the management of diabetic foot ulcers across the UK. PARTICIPANTS: Patients over age 18 with type 1 or type 2 diabetes with a chronic (present for at least 6 weeks) full-thickness foot ulcer (on or below the malleoli) not penetrating to tendon, periosteum or bone, and with a cross-sectional area between 25 and 2500 mm(2). INTERVENTIONS: Participants were randomised 1:1:1 to treatment with one of N-A (a non-adherent, knitted, viscose filament gauze), Inadine (an iodine-impregnated dressing), both traditional dressings, or Aquacel, a newer product. MAIN OUTCOME MEASURES: The primary outcome measure was the number of ulcers healed in each group at week 24. Secondary measures included time to healing, new ulcerations, major and minor amputations, and episodes of secondary infection. RESULTS: A total of 317 patients were randomised. After 88 withdrawals, 229 remained evaluable. A greater proportion of smaller (25-100 mm(2) ulcers healed within the specified time (48.3% versus 37.3%; p = 0.048). There was, however, no difference between the three dressings in terms of percentage healed by 24 weeks, or in the mean time to healing, whether analysed on the basis of intention to treat (Inadine 44.4%, N-A 38.7%, Aquacel 44.7%; not significant) or per protocol (Inadine 55.2%, N-A 59.4%, Aquacel 63.0%; not significant). There was no difference in the quality of healing, as reflected in the incidence of recurrence within 12 weeks. Likewise, there was no difference in the incidence of adverse events, although a greater proportion of those randomised to the non-adherent dressings were withdrawn from the study (34.9% versus 29.1% Aquacel and 19.4% Inadine; p = 0.038). The only statistically significant difference found in the health economic analysis was the cost associated with the provision of dressings (mean cost per patient: N-A 14.85 pounds, Inadine 17.48 pounds, Aquacel 43.60 pounds). The higher cost of Aquacel was not offset by the fewer dressings required. There was no difference in measures of either generic or condition-specific measures of quality of life. However, there was a significant difference in the change in pain associated with dressing changes between the first and second visits, with least pain reported by those receiving non-adherent dressings (p = 0.012). There was no difference in the costs of professional time, and this may relate to the number of dressing changes undertaken by non-professionals. Fifty-one per cent of all participants had at least one dressing change undertaken by themselves or a non-professional carer, although this ranged from 22% to 82% between the different centres. CONCLUSIONS: As there was no difference in effectiveness, there is no reason why the least costly of the three dressings could not be used more widely across the UK National Health Service, thus generating potentially substantial savings. The option of involving patients and non-professional carers in changing dressings needs to be assessed more formally and could be associated with further significant reductions in health-care costs. TRIAL REGISTRATION: Current Controlled Trials ISRCTN78366977.

Excessive calcium ingestion leading to milk-alkali syndrome.

This report describes the presentation and clinical course of a 40-year-old woman who had an emergency admission for eclampsia. During routine investigations, she was found to have profound hypercalcaemia, the cause of which was identified as milk-alkali syndrome, caused by self-medication with antacid tablets for dyspepsia. Treatment with aggressive rehydration, bisphosphonates and discontinuation of antacid tablets restored normocalcaemia. The patient made a full recovery with no long-term side-effects. Her male infant was safely delivered with no deleterious effects of exposure to high calcium concentrations in utero.

The health status of diabetic patients receiving orthotic therapy.

Diabetes has a major impact on the quality of life and those with related foot ulcers are among those most affected. The main aim of the study, which was carried out over an 18-month time period, was to compare the self-reported health status of a group of diabetic patients receiving orthotic therapy with that of other groups who did not receive the therapy. A sample of 280 was recruited from patients with type I and type II diabetes. The study group comprised four groups of patients: those receiving orthotic therapy (insoles) for pedal complications as a result of their diabetes; those with diabetes mellitus, without complications of the disease affecting their foot; those with unilateral lower limb amputation and those with active ulceration who had not been prescribed footwear. The specialised orthotic intervention resulted in statistically significant improvements in health status (p < 0.05), (measured using the SF-36) both physically and mentally, for patients with at-risk feet and should become an integral part of the treatment regime for diabetics with at-risk feet.

Diabetes: the Nature of the Disease.

The cause of diabetes may be primary or secondary. Primary diabetes is divided into insulin-dependent diabetes mellitus (IDDM) or type I diabetes, and non-insulin-dependent diabetes mellitus (NIDDM) or type II diabetes, with the two representing different diseases from an epidemiological viewpoint. Secondary diabetes is caused by liver, pancreatic and endocrine disease, in addition to genetic syndromes and drugs.

Bilateral renal cortical abscesses in a young woman with type 1 diabetes.

Serious complications of urinary tract infection, such as papillary necrosis or perinephric abscess, occur more frequently in diabetic patients. However, severe bilateral renal parenchymal infection with multiple intrarenal abscesses is not well recognized. We described an 18-year-old insulin-dependent diabetic woman with such infection, in whom renal imaging showed progression to a major perinephric abscess, but only after 5 weeks of intensive antibiotic therapy. Complete recovery followed surgical drainage and no renal cortical scarring was present on computerized tomographic scan 18 months later.

Oral glucose decreases hepatic extraction of insulin.

Peripheral venous (plasma) insulin and C-peptide concentrations were measured in eight normal subjects given oral or intravenous glucose sufficient to produce similar plasma glucose concentrations. The expected increased insulin response to oral as compared with intravenous glucose was not matched by a comparable increase in C-peptide concentration. The ratio of insulin to C-peptide concentrations doubled 30 minutes after oral glucose was given; no comparable rise was seen with intravenous glucose (p = 0.01). This finding is interpreted as evidence for decreased hepatic extraction of insulin after administration of oral glucose. Such a decrease could account for at least half of the well known difference in peripheral insulin concentrations after administration of oral as compared with intravenous glucose.

Renal and pancreatic transplantation in the treatment of diabetic renal failure.

Twenty-two diabetic patients with renal failure have entered an integrated dialysis and transplant programme in 30 months. Ten have subsequently undergone combined renal and segmental pancreatic transplantation, and have been followed for between one month and 25 months. Currently 80 per cent of the kidneys and 40 per cent of the pancreatic grafts are functioning. Four of the 22 patients have died from myocardial disease. Pancreatic transplantation at the time of renal grafting in diabetics does not significantly increase morbidity, and currently offers a 40 per cent chance of freedom from exogenous insulin. The successful treatment of diabetic renal failure is not compromised by the addition of this developmental procedure.

Pancreatic society of great britain and ireland: annual meeting, 1980: second scientific session.

With the increase in the number of diabetic patients in renal failure new attempts are being made to improve both the results of cadaveric transplantation and the quality of rehabilitation. A combined approach of renal and segmental pancreatic transplantation has been made in patients with major diabetic complications. We here report the early Cambridge experience using this management.