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Table 1 Characteristics of included studies

From: Is an increase in skin temperature predictive of neuropathic foot ulceration in people with diabetes? A systematic review and meta-analysis

Reference Title Objective Study design Population Temperature-monitoring Sites measured Temperature control Outcome
Armstrong 1996 Monitoring Neuropathic Ulcer Healing with Infrared Dermal Thermometry. To prospectively evaluate skin temperatures at the site of neuropathic ulceration before, during, and after wound healing using the contralateral extremity as a physiologic control and to evaluate variables that may influence skin temperature gradients. Longitudinal. Location: USA Foot temperatures were taken at weekly cast changes and for the first four months after return to shoes. The anatomical site of ulceration. Contralateral limb was used as control. Skin temperature gradient was a mean of 6.9°F higher on the ulcerated site than at the same anatomical site on the contralateral limb when the initial total contact cast was applied (91.1 vs 84.2°F). At the end of total contact casting, Armstrong 1996 found no significant difference in skin temperature between the previously ulcerated site and the same site on the contralateral limb (83.4 vs 85.3°F).
Group 1 Number: 25
Age: mean 52.4, SD 11.6 Temperatures were taken using a hand-held, infrared skin temperature probe (Exergen DT 1001).
Groups: All patients had grade I ulcerations. All patients had loss of protective sensation.
Temperatures were also measured at 2, 4 and then 8 week intervals after transfer to shoe gear for four months following return to shoe gear.
Armstrong 1997a Monitoring Healing of Acute Charcot’s Arthropathy with infrared Dermal thermometry. Describe the use of skin temperature assessment in diabetics with acute Charcot's arthropathy to monitor resolution of inflammation longitudinally throughout the course of treatment and to predict development of neuropathic ulcers. Longitudinal. Location: USA Total contact casts changed weekly in patients with ulcerations. No ulcers (changed after 3 weeks at most). The anatomical site of ulceration. Contralateral limb was used as control. There was no significant difference in skin temperature gradients on initial presentation between ulcerated and non- ulcerated subjects (1.5+/−1.1 vs 2.2+/−1.4°F). However, all patients in the study had acute Charcot’s arthropathy at this time.
Number: 39
Group 1 Age: mean 59, SD 9.5
Groups: All patients had acute Charcot’s arthropathy, diabetes, loss of protective sensation and palpable pedal pulses. Measured temp on seven sites on sole of the foot and on the anterior ankle. During the follow-up period of this study, three participants with inactive Charcot’s arthropathy had ulcerated under the forefoot. At their visits prior to re-ulceration, temperature gradients between the ulcerated and non-ulcerated foot were significantly higher than those of other patients seen at that clinic (4.5+/−0.9 vs 0.9+/−0.9°F).
17 patients initially presented with concomitant grade 1A ulceration also.
Armstrong 1997b Infrared Dermal Thermometry for the High-Risk Diabetic Foot. Compare skin temperatures in patients with asymptomatic peripheral sensory neuropathy, patients with neuropathic ulcers, and patients with Charcot’s arthropathy using the contra-lateral limb as control. Cohort study. Location: USA Temperatures were taken using a hand-held, infrared skin temperature probe (Exergen DT 1001). Great toe, the first metatarsocuneiform joint, the cuboid and the first, third and fifth metatarsal heads. Contralateral limb. There were differences in skin temperature between the affected foot and the contralateral foot among the patients with neuropathic ulcers (3.1°C) patients with neuropathic ulcers experienced re-ulceration a mean of 12.2 months after initial healing, with a corresponding increase in skin temperature 3.2°C vs. 28°C at the clinical visit preceding injury.
Number: 143
Group 1 Mean age: 63.9 Temps were taken by the study physician when casts were checked (no longer than 3 weeks).
Groups – Asymptomatic sensory neuropathy (n=78), Ulcers (n=44), Charcot (n=21).
Armstrong 2007 Skin Temperature-monitoring Reduces the Risk for Diabetic Foot Ulceration in High-risk Patients. To evaluate the effectiveness of home temperature-monitoring to reduce the incidence of foot ulcers in high-risk patients with diabetes. Randomised controlled trial. Location: USA Both groups involved therapeutic footwear, diabetic foot education, regular foot care and a structured daily foot inspection. Six foot sites (not reported in the article). Contralateral limb. Treatment and control groups demonstrated no significant differences in descriptive characteristics (p>0.05). Total of 8.4% ulcerated (n=19). 12.2% (n=14) ulcerated in the standard therapy group. 4.7% (n=5) ulcerated in the dermal thermometry group. Ulcerating patients had a temp difference that was 4.8 times greater in the region of the ulceration.
Group 1 and Prevention Number: 225
Mean age: 69
Groups: Standard therapy (n=115) Dermal thermometry (n=94). The dermal thermometry also involved skin temperature-monitoring using the TempTouch device.
Temperature difference >4°F between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperature normalised.
Armstrong 2003 Skin Temperatures as a One-time screening Tool Do Not Predict Future Diabetic Foot Complications. Are baseline mean skin temperature measurements useful in predicting the most common foot-related complications of diabetes mellitus? Prospective longitudinal study. Location: USA Temperatures were taken using a hand-held, infrared skin temperature probe (Exergen DT 1001). Great toe, the first metatarsocuneiform joint, the cuboid and the first, third and fifth metatarsal heads. All 12 measurements were averaged. Participants in the study who did not ulcerate. There was no difference in the mean foot temperature of participants who had ulcers compared to participants who did not have ulcers during the study.
Group 2 Number: 1588
Mean age: 69
Groups: number of variable groups. This meta-analysis only used data of patients who developed ulcerations and those who did not.
Benbow 1994 The Prediction of Diabetic Neuropathic Plantar Foot Ulceration by Liquid-Crystal Contact Thermography. To assess whether the development of plantar foot ulceration could be predicted from the mean foot temperature (MFT) as assessed by liquid crystal thermometry in patients with peripheral neuropathy. Cohort study. Location: UK Temperatures were taken using liquid crystal thermometry. First to fifth metatarsal heads, navicular, cuboid and plantar heel. All 16 measurements were averaged. Non-diabetic paticipants. Without PVD participants: At follow-up seven feet had developed ulcerations. The initial MFT in the seven feet that developed plantar ulcers (30.5+/− 2.6C) was significantly higher than in the 38 feet that did not develop ulcers (27.8 +/− 2.3C).
Group 2 Number: 50
Mean age: 56.3
Groups: Diabetic neuropathic peripheral vascular disease (PVD), diabetic neuropathic without PVD and non diabetic non PVD.
With PVD participants: No results available.
Stess 1986 Use of Liquid Crystal Thermography in the Evaluation of the Diabetic Foot. Identify thermal emission patterns associated with diabetic foot ulcers. Case control. 3 groups. Location: USA Liquid crystal thermography. Entire plantar surface. Non-diabetic participants. In patients with unilateral ulcerations, no significant temperature difference was detected between the affected and unaffected feet under the met heads, hallux of heels.
Group 2 Number: 65
Mean age – not indicated
Groups: Group 1 – no history of diabetes (16), Group 2 – no history of, or active foot ulceration (21) Group 3 – active or history of plantar ulceration (28) 13 presented with active ulceration.
Lavery 2007 Preventing Diabetic Foot Ulcer Recurrence in High-Risk Patients. Evaluate the effectiveness of a temperature-monitoring instrument to reduce the incidence of foot ulcers in individuals with diabetes who have a high risk for lower extremity complications. Randomised controlled trial. Location: USA Temperatures were taken using a hand-held, infrared skin temperature probe (Exergen DT 1001). The great toe, the first, third and fifth metatarsal heads, the mid-foot and the heel. Contralateral limb. Fewer ulcers developed in the enhanced therapy group than the standard therapy group and the structured foot examination group (enhanced therapy 8.5 vs. standard therapy 29.3%, p = 0.0046 and enhanced therapy vs. structured foot examination 30.4%, p = 0.0029). Patients in the standard therapy and structured foot examination were 4.37 and 4.71 times more likely to develop ulcers than patients in the enhanced therapy group.
Prevention Number: 173
Age: mean 64.9 Each group received therapeutic footwear, diabetic foot education and regular foot care. Subjects in the structured foot examination group performed structured foot examinations daily. Patients were to contact the nurse if they noted any abnormalities. Subjects in the enhanced therapy group measured foot temperatures on six sites, daily. If a temperature difference of 4°F was noted between limbs, patients were to inform the study nurse.
M:F: 93:80
Groups: Three groups – standard therapy, enhanced therapy and structured foot examination.
Lavery 2004 Home Monitoring of Foot Skin Temperatures to Prevent Ulceration. To evaluate the effectiveness of at-home infrared temperature-monitoring as a preventative tool in individuals at high risk for diabetes-related lower-extremity ulceration and amputation. Randomised controlled trial. Location: USA Temperatures were taken using a hand-held, infrared skin temperature probe (Exergen DT 1001). The great toe, the first, third and fifth metatarsal heads, the central mid-foot and the heel. Contralateral limb. The enhanced therapy group had significantly fewer foot complications (enhanced therapy group 2% vs. standard therapy group 20%, p = 0.01, odds ratio 10.3, 95% CI 1.2-85.3). There were seven ulcers and two Charcot fractures among standard therapy patients and one ulcer in the enhanced therapy group.
Prevention Number: 85
Age: mean 54.9 Standard therapy involved therapeutic footwear, diabetes foot education and regular foot evaluation by a podiatrist. Enhanced therapy included the addition of a handheld infrared skin thermometer to measure temperatures n the sole of the foot in the morning and evening. When skin temperature differences were more than 4°F.
M:F: 43: 42
Groups: Standard therapy and enhanced therapy group.