Introduction
Methods
Eligibility criteria
Outcomes
Searches
Trial selection and data extraction
Risk of bias (quality) assessment
Data analysis
Results
Author | Population characteristics | Details of experimental and control interventions | Standard care | Outcomes (unit of analysis) Length of follow-up | Risk of biasa |
---|---|---|---|---|---|
Education | |||||
Monami 2015 [34] | n = 121 (I = 61, C = 60) Male: 60% Mean age: 71 years Previous ulcers: 11% T2DM: 100% Mean diabetes duration: 15 years Ulcer risk: high Participants defined as ‘high risk’ if neuropathy diagnosed, previous diabetic foot ulcer or foot abnormalities | Intervention: brief educational programme 2 h programme provided by a physician (for 15 min) and nurse (for 105 min) to groups of five to seven participants: 30 min face-to-face lesson on risk factors for foot ulcers and 90 min interactive session with practical exercises on behaviours for reducing risk Control: brief leaflet and standard care | All participants had previously received standard multidisciplinary education for diabetes (with a structured group programme at diagnosis or first contact, and follow-up meetings every 2 years) | Ulcers (n), amputation (n), mortality (n), knowledge score, time spent for intervention and ulcer care in control group (min per participant) Follow-up: 6 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: – Incomplete data addressed: – Selective reporting: + Sample size calculated: + |
Annersten Gershater 2011 [35] | n = 131 (I = 61, C = 70) Male: 73% Mean age: 64 years Previous ulcers: 100% T2DM: 67% Mean diabetes duration: NR Ulcer risk: high (IWGDF) | Intervention: group session of foot care education from a registered diabetes nurse Oral and written instructions on self-care based on IWGDF guidelines 1× 60 min plus standard care Control: standard information, oral and written instructions on self-care based on IWGDF guidelines | Routine care from staff Adjusted shoes for indoor and outdoor use and individually fitted insoles | Ulcers (n), cause of ulcers (stress, trauma, other), location of ulcers (big toe or other, plantar, other including heel) Follow-up: 6 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: – Incomplete data addressed: + Selective reporting: + Sample size calculated: + |
Lincoln 2008 [36] | n = 172 (I = 87, C = 85) Male: 67% Mean age: NR Previous ulcers: 100% T2DM: 77% Mean diabetes duration: NR Ulcer risk: high (10 g monofilament, Neurotip, VPT ≥25 V) | Intervention: 1 h structured foot care education session provided by the researcher in participants’ own homes Control: standard care and the same foot care leaflets as the intervention group | Regular podiatry and suitable orthoses when appropriate Overall medical care followed national UK clinical guidelines | Ulcers (n), amputations (n), quality of life (DFS-SF), mood (HADS, HADS-anxiety, HADS-depression), protective foot care behaviours (NAFF) Follow-up: 6 and 12 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: + |
Dermal infrared thermometry | |||||
Armstrong 2007 [37] | n = 225 (I = NR, C = NR) Male: 96% Mean age: 69 years Previous ulcers: unclear T2DM: 100% Mean diabetes duration: 13 years Ulcer risk: IWGDF risk group 2/3 | Intervention: infrared thermometry and a complex intervention provided by attending physicians Control: a complex intervention only | Footwear, education and professional foot care | Ulcers (n, %), rate of ulcer (HR), temperature difference at ulcer site (survival curve) Follow-up: 18 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: ? Sample size calculated: + |
Lavery 2004 [38] | n = 85 (I = 41, C = 44) Male: 49% Mean age: 55 years Previous ulcers: 41% T2DM: NR Mean diabetes duration: 14 years Ulcer risk: IWGDF risk group 2/3 | Intervention: infrared thermometry and a complex intervention provided by treating physician (evaluation), nurse case manager (contact) and podiatrist (follow-up) Control: complex intervention; foot evaluation by a podiatrist every 10–12 weeks, therapeutic footwear, diabetic foot education | Footwear, education and professional foot care | Foot complications: ulcers, Charcot foot, infection and amputation (n) Quality of life: pre- and post-physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health (SF-36 scores) Follow-up: 6 months | Sequence generation: ? Allocation concealment: ? Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: – |
Lavery 2007 [39] | n = 173 (I1 = 59, I2 = 56, C = 58) Male: 54% Mean age: 65 years Previous ulcers: 100% T2DM: 95% Mean diabetes duration: 13 years Ulcer risk: high (10 g monofilament, VPT ≥25 V, palpation of pulses, Doppler, ankle brachial index ≥0.07) | Infrared thermometry and a complex intervention; study nurse for contact, treating physician for foot evaluations, podiatrist for assessing shoes/insoles I1: enhanced care with infrared thermometry I2: structured care with a structured daily foot self-inspection Control: standard care | Lower-extremity evaluation, education programme, therapeutic insoles and footwear All participants received a pedometer to record their daily activity in a log book Participants were told to inspect their feet daily and to contact a nurse if necessary | Foot ulcers (n), foot trauma, fracture, death, osteomyelitis, time to ulceration (days) Follow-up: 15 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: + |
Skafjeld 2015 [40] | n = 41 (I = 21, C = 20) Male: 56% Mean age: 58 years Previous ulcers: 100% T2DM: 71% Mean diabetes duration: 18 years Ulcer risk: IWGDF risk group 3 | Intervention: foot skin temperature monitoring, theory-based counselling provided by study nurse, contact study nurse if increase in temperature for >2 days Control: standard care | Foot care and recording observations daily, customised footwear | Ulcer (n), increased skin temperature (°C), customised footwear worn (h/day), contacts with study nurse Follow-up: 12 months | Sequence generation: + Allocation concealment: ? Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: – |
Complex interventions | |||||
Cisneros 2010 [41] | n = 53 (I = 30, C = 23) Male: 62% Mean age: 62 years Previous ulcers: 28% T2DM: 96% Mean diabetes duration: 14.5 years Ulcer risk: IWGDF risk group (I/C) 1 (6/10), 2 (15/7), 3 (3/3) or 4 (6/3) | Intervention: complex intervention Therapeutic education in groups of eight, 4× 90 min provided by researcher, two pairs of protective shoes, testing for neuropathy Control: information on regular foot care and footwear use according to spontaneous demand during individual consultations with the researcher | Routine care from staff, instructions on foot care when requested, testing for neuropathy | Ulcer occurrence (n), ulcer recurrence (n), time to foot ulceration (survival time – quarterly evaluations) Follow-up: 24 months Ulcerations were noted to occur more frequently in those at high risk | Sequence generation: ? Allocation concealment: ? Assessor blinding to outcome data: + Incomplete data addressed: ? Selective reporting: + Sample size calculated: – |
LeMaster 2008 [42] | n = 79 (I = 41, C = 38) Male: 51% Mean age: 66 years Previous ulcers: 42% T2DM: 94% Mean diabetes duration: 11 years Ulcer risk: moderate or high risk | Intervention: complex intervention Part 1 (1–3 months): physical therapist led exercises to strengthen lower-extremity muscles and promote balance over eight sessions Part 2 (4–12 months): increase in moderately intense activity by 50% over 12 months among community-dwelling participants Provided by physical therapist and study nurse Control: standard care | Foot-related self-care skill education, daily foot examination Usual medical care from their own healthcare providers Participants were referred to orthotists or podiatrists for therapeutic footwear at enrolment | Foot ulcer rates (lesions/lesion episode, full-thickness ulcer/ulcer episode, weight-bearing full-thickness plantar ulcer/ulcer episode) (n) Step activity, person-years at risk Follow-up: 12 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: + Selective reporting: + Incomplete data addressed: + Sample size calculated: + |
Liang 2012 [43] | n = 62 (I = 31, C = 31) Male: 56% Mean age: 56 years Previous ulcers: 0% T2DM: 87% Mean diabetes duration: 11 years Ulcer risk: ADA risk category 1/2/3 High risk, n = 100% | Intervention: complex intervention Foot care kit containing foot care cream, 10 g monofilament, thermometer to measure water temperature for washing feet, alcohol cotton pieces and a mirror Daily foot care and diabetes education classes provided by a diabetes nurse-led multidisciplinary team (three endocrinologists, four nurses and one dietitian) Control: standard care | Conventional care alone according to ADA standards; medication adjustment, foot assessment and 2 h of education about diabetes foot care | Ulcers (n, %), amputation (n, %), HbA1c (%), diabetes knowledge, foot care behaviour Follow-up: 24 months | Sequence generation: ? Allocation concealment: ? Assessor blinding to outcome data: ? Selective reporting: ? Incomplete data addressed: + Sample size calculated: – |
Litzelman 1993 [44] | n = 396 (I = 191, C = 205) Male: 19% Mean age: 60 years Previous ulcers: NR T2DM: 100% Mean diabetes duration: 10 years Ulcer risk: NR | Intervention: participant education sessions, self-foot care, reinforced through telephone follow-up (2 weeks) and postcard reminder (1 and 3 months) Informational flow sheets on foot-related risk factors for amputation in individuals with diabetes Prompts for healthcare providers to: (1) ask that participants remove their footwear; (2) perform foot examinations; and (3) provide foot care education Provided by nurse clinicians Control: care as usual plus standard care | 1 year after the initial assessment, all participants underwent a repeated history and physical examination performed by nurse clinicians blind to participants’ randomised treatment | Participant outcomes: participant behaviour (scale) Behaviour of healthcare provider (%) Physical findings (ulcers, physical examination, dry/cracked skin, corns, calluses, ingrown nails, fungal infections, improperly trimmed nails, foot/leg cellulitis, leg deformity, sensory examination) (%) Follow-up: 12 months | Sequence generation: ? Allocation concealment: ? Assessor blinding to outcome data: + Selective reporting: + Incomplete data addressed: ? Sample size calculated: – |
McCabe 1998 [45] | n = 1997 randomised (I = 997, C = 1000) Male: 53% Mean age: 60 years Previous ulcers: unclear T2DM: 80% Mean diabetes duration: NR Ulcer risk: low, moderate, high Ankle brachial index ≤0.75, history of foot ulcers = high risk | Intervention: primary foot screening examination with a biothesiometer and palpation of pedal pulses Foot pressures, subcutaneous oxygen levels, ankle brachial indices and X rays, weekly diabetic foot clinic for high-risk participants Provided by general diabetic outpatient clinic Control: participants were silently tagged and continued to attend the general outpatient clinic, but received no additional care | Participants were advised to inspect and wash their feet daily, avoid constricting clothing and footwear, wear prescribed footwear at all times and contact the clinic whenever they thought it necessary | Participant outcomes: ulcers (n), ulcer progressing to amputation (%) Process outcomes: screening cost (£), compliance with follow-up/treatment (%) Follow-up: 24 months | Sequence generation: ? Allocation concealment: ? Assessor blinding to outcome data: ? Selective reporting: + Incomplete data addressed: + Sample size calculated: – |
Custom-made footwear and offloading | |||||
Bus 2013 [46] | n = 171 (I = 85, C = 86) Male: 82.5% Mean age: 62 years Previous ulcers: 100% T2DM: 71% Mean diabetes duration: 17 years Ulcer risk: high (assessed with 10 g monofilament and vibration perception plus pedis tests) | Intervention: custom-made footwear, of which the offloading properties were improved and subsequently preserved based on in-shoe plantar pressure measurement and analysis A local specialist provided the footwear and a local orthopaedic shoe technician manufactured the footwear Control: custom-made footwear that did not undergo improvement based on in-shoe pressure measurement (i.e. usual care) | Each participant received written and verbal instructions on foot care and on proper use of footwear All footwear in both study groups was evaluated at delivery and at 3 month follow-up visits (pressure measurements, temperature monitor and activity monitor) | Ulcer recurrence (participants with ulcer, previous ulcer location, complicated foot ulcers); ulcer recurrence according to adherence and non-ulcerative lesions (all in n, %); in-shoe peak pressure, daily step count, adherence (mean ± SD) Follow-up: 18 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: + |
Reiber 2002 [47] | n = 400 (I1 = 121, I2 = 119, C = 160) Male: 77% Mean age: 62 years Previous foot ulcers or infection requiring antibiotics: 100% T2DM: 93% Mean diabetes duration: <6 years: 33% 6–24 years: 11% ≥25 years: 56% Ulcer risk: high (assessed by 10 g monofilament and presence of foot deformity) | Therapeutic shoes with two types of inserts and standard care; provided by the study pedorthist provided and evaluated by a panel of three foot care specialists Intervention 1: three pairs of therapeutic shoes and customised medium-density cork inserts with a neoprene closed-cell cover Intervention 2: three pairs of therapeutic shoes and prefabricated, tapered polyurethane inserts with a brushed nylon cover Control: usual footwear and standard care | Participants continued to receive regular healthcare and foot care from the VA or GHC A lightweight terry-cloth house slipper (Tru-Stitch Footwear, Malone, NY, USA) with no internal seam and a textured sole was designed for all participants to use to minimise differences in out-of-shoe exposure | Lesions and ulcers (ulcers, non-ulcerative, total, person-years of follow-up); incidence per person (n participants with ≥1 ulcer, cumulative incidence per person, RR); incidence per person-year (ulcer and ulcer episode, n; incidence, RR); pivotal events for ulcer episodes (shoe and non-shoe related) (all in n and 95% CI) Follow-up: 24 months The majority of ulcers developed in those with foot insensitivity | Sequence generation: + Allocation concealment: ? Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: + |
Rizzo 2012 [48] | n = 298 (I = 148, C = 150) Male: NR Mean age: 67 years Previous ulcers: 20% T2DM: 84% Mean diabetes duration: 18 years Ulcer risk: high (IWGDF risk group ≥2) | Intervention: orthoses and shoes, plus standard care Screening by an experienced podologist; foot and current ulcer risk evaluated by a team of a diabetologist, podologist, and orthopaedic technician Control: standard care | In-depth education on preventing ulceration, advice regarding footwear Urgent consultation within 24 h if ulcers developed | Foot ulcer (participants n), new foot ulcers (n), cumulative incidence of ulcers and recurrences (3 and 5 years; χ2, % and p value), ulcer due to trauma or hyperpressure (n, %), VPT (mean ± SD), cost evaluation (€) Follow-up: 12 months | Sequence generation: + Allocation concealment: ? Assessor blinding to outcome data: – Incomplete data addressed: + Selective reporting: + Sample size calculated: – |
Lavery 2012 [49] | n = 299 (I = 149, C = 150) Male: 67% Mean age: 70.5 years Previous ulcers: 26.95% T2DM: NR Mean diabetes duration: 12.5 years Ulcer risk: high (IWGDF risk group 2/3) | Intervention: shear-reducing insole and complex intervention Concerns addressed by study nurse, evaluation conducted by a physician Control: standard care | Foot and lower-extremity evaluation by a physician every 10–12 weeks, education programme focused on foot complications and self-care practices Therapeutic shoes and standard insoles Contact with study nurse if concerned | Ulcers (n, %), footwear compliance (4, 4–8, 8–12, 12–16 h/day; n, %), time to ulcer (HR) Follow-up: 18 months | Sequence generation: ? Allocation concealment: ? Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: + |
Ulbrecht 2014 [50] | n = 150 (I = 79, C = 71) Male: 68% Mean age: 59.5 years Previous ulcers: 100% T2DM: NR Mean diabetes duration: NR Ulcer risk: high (inability to feel 10 g monofilament, high plantar pressure, ankle brachial index) | Intervention: bespoke orthoses with offloading properties, provided by study coordinators (clinicians) Control: three different manufacturers’ orthoses plus three pairs of identical orthoses to be rotated while using the primary study footwear according to a written rotation protocol, changing the numbered orthoses in a set rotation every month; also offered one of two types of footwear models | Education on self-care behaviours with all participants, with a focus on wearing the study shoes for all steps taken and on examining the feet daily to note and report problems Educational brochure to reinforce advice | Ulcers (n, %), peak barefoot plantar pressure vs lesion (ulcer, non-ulcerative, no lesion; kPa) Questionnaires for quality of life (scaled to 100), foot self-care (0–1), fear of falling (scale to 100), participant satisfaction (five-point Likert scale) Follow-up: 1, 3 and 6 weeks, then every 3 months for another 15 months (potential 16.5 months) | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: + |
Uccioli 1995 [51] | n = 69 (I = 33, C = 36) Male: 62% Mean age: 60 years Previous ulcers: 100% T2DM: 75% Mean diabetes duration: 17 years Ulcer risk: high (mean VPT ≥25 V) | Intervention: therapeutic shoes with custom insoles specially designed for individuals with diabetes (Podiabetes by Burrato Italy) Control: participants were free to wear ordinary shoes or their own non-therapeutic shoes unless clearly dangerous | All participants received the same educational guidelines on foot care and general information on the importance of appropriate footwear (i.e. proper size, durability and sole) | Ulcer relapses (n, %), cumulative incidence of relapse (multiple regression analysis), ulcer relapse between groups (χ2, %, p value), ulcer-free time, peripheral neuropathy (VPT, peripheral vascular disease), ankle brachial index (mean ± SD), use of therapeutic shoes Follow-up: 12 months | Sequence generation: ? Allocation concealment: ? Assessor blinding to outcome data: ? Incomplete data addressed: + Selective reporting: + Sample size calculated: – |
Digital silicone devices | |||||
Scirè 2009 [32] | n = 167 (I = 89, C = 78) Male: NR Mean age: 56.5 years Previous ulcers: unclear T2DM: 88% Mean diabetes duration: 16 years Ulcer risk: high (VPT ≥25 V) | Intervention: digital silicone orthoses (Podikon, Epitech, Saccolongo, Italy) and regular care at the diabetic foot clinic Control: no orthoses, but regular care at the diabetic foot clinic | Callus management; soft insole and extra-deep shoe | Ulcers (%), hyperkeratosis (plantar, dorsal, interdigital; %), skin hardness (%) Stable deformities (%) Podobarometric evaluationb (pre- and post-evaluation in mean ± SD) Follow-up: 3 months | Sequence generation: + Allocation concealment: ? Assessor blinding to outcome data: + Incomplete data addressed: + Selective reporting: + Sample size calculated: – |
Antifungal nail lacquer | |||||
Armstrong 2005 [30] | n = 70 (I = 34, C = 36) Male: 97% Mean age: 70 years Previous ulcer: 57% T2DM: NR Mean diabetes duration: 12 years Ulcer risk: high (IWGDF risk group 2/3) | Intervention: antifungal treatment (ciclopirox 8%) and self-management (daily inspection) Control: self-management (daily inspection) A staff podiatrist examined each participant at recruitment A clinician familiar with the care and status of participants staffed a foot hotline 24 h/day | Preventative care programme and telephone support | Ulcers, unexpected visits, missed appointments, tinea pedis/ hyperkeratosis at start and end of study (%) Follow-up: 12 months | Sequence generation: + Allocation concealment: ? Assessor blinding to outcome data: ? Incomplete data addressed: + Selective reporting: + Sample size calculated: – |
Elastic compression stockings | |||||
Belcaro 1992 [31] | n = 160 (I = 80, C = 80) Male: 50% Mean age: 53 years Previous ulcers: none T2DM: NR Mean diabetes duration: 15 years Ulcer risk: microangiopathy measured with laser Doppler, VPT also measured | Intervention: knee elastic stockings with compression at the ankle of 25 mmHg, worn for at least 6 h/day while active and/or working Control: no stockings | NR | Ulcers (n, %), number of limbs (n) Deterioration of microcirculation Supine resting flux (mean ± SD) Venoarteriolar response (median and range) Follow-up: 48 months | Sequence generation: ? Allocation concealment: – Assessor blinding to outcome data: – Incomplete data addressed: + Selective reporting: + Sample size calculated: – |
Podiatric care | |||||
Plank 2003 [33] | n = 91 (I = 47, C = 44) Male: 56% Mean age: 65 years Previous ulcers: 100% T2DM: 93% Mean diabetes duration: 16 years Ulcer risk: high (reduced sensation assessed by 128 Hz tuning fork, 5.07 monofilament) | Intervention: chiropodist care and standard care Control: chiropodist care and standard care according to participant preference | Instruction on the possible benefits of regular chiropody care and the aim of the study | Ulcers (feet and participants), death, amputation (n, %). Follow-up: 12 months | Sequence generation: + Allocation concealment: + Assessor blinding to outcome data: ? Incomplete data addressed: + Selective reporting: + Sample size calculated: – |