Effect of thermometry on the prevention of diabetic foot ulcers: *

Authors’ contribution

Study concept and design: Açucena Leal de Araújo, Francisca Diana da Silva Negreiros, Thereza Maria Magalhães Moreira. Obtaining data: Açucena Leal de Araújo, Francisca Diana da Silva Negreiros, Raquel Sampaio Florêncio, Shérida Karanini Paz de Oliveira, Ana Roberta Vilarouca da Silva. Data analysis and interpretation: Açucena Leal de Araújo, Francisca Diana da Silva Negreiros, Raquel Sampaio Florêncio, Shérida Karanini Paz de Oliveira, Ana Roberta Vilarouca da Silva, Thereza Maria Magalhães Moreira. Statistical analysis: Açucena Leal de Araújo, Raquel Sampaio Florêncio, Thereza Maria Magalhães Moreira. Drafting the manuscript: Açucena Leal de Araújo, Francisca Diana da Silva Negreiros, Shérida Karanini Paz de Oliveira, Ana Roberta Vilarouca da Silva, Thereza Maria Magalhães Moreira. Critical review of the manuscript as to its relevant intellectual content: Açucena Leal de Araújo, Francisca Diana da Silva Negreiros, Raquel Sampaio Florêncio, Shérida Karanini Paz de Oliveira, Ana Roberta Vilarouca da Silva, Thereza Maria Magalhães Moreira. All authors approved the final version of the text.

Conflict of interest

The authors have declared that there is no conflict of interest.

Author/ Year/ Country	Characteristics of the sample	Intervention Group/Control Group			Main results
Armstrong, et al.¹⁶16. Armstrong DG, Holtz-Neiderer K, Wendel C, Mohler MJ, Kimbriel HR, Lavery LA. Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-risk Patients. Am J Med. 2007 Dec;120(12):104-6. doi: https://doi.org/10.1016/j.amjmed.2007.06.028 https://doi.org/https://doi.org/10.1016/... 2007. United States.	n=225 (IG*: 110, CG^†: 115) Male: 96% Mean age: 69 years old DM2^‡: 100% Mean time since DM diagnosis: 13 years Risk of ulcer: 2/3 (IWGDF^§)	Duration: 18 months Outcomes: Proportion of patients in each group who developed foot ulcers	IG*: Handheld infrared thermometer and recording in diary	CG^†: Therapeutic footwear, education on diabetes, regular foot care and recording in diary	Incidence of foot ulcers: IG*: 4.7% (n=5/NR^\|\|), CG^†: 12.2% (n=14/NR^\|\|)
Bus, et al.³¹31. Bus SA, Stegge WB, Baal JG, Busch-Westbroek TE, Nollet F, Netten JJ. Effectiveness of at-home skin temperature monitoring in reducing the incidence of foot ulcer recurrence in people with diabetes: a multicenter randomized controlled trial (DIATEMP). BMJ Open Diabetes Res Care. 2021 Sep;9(1):e002392. doi: https://doi.org/10.1136/bmjdrc-2021-002392 https://doi.org/https://doi.org/10.1136/... 2021. Holland	n=304 (IG*: 151, CG^†: 153) Male: 72.4% Mean age: 65 DM2^‡: 77% Mean time since DM diagnosis: 20 years Risk of ulcer: 2/3 (IWGDF^§)	Duration: 18 months Outcomes: Proportion of patients in each group who developed foot ulcers	IG*: Handheld infrared thermometer and recording in a standardized form developed by the researcher.	CG^†: Foot assessment and foot screening once every 1-3 months by a podiatrist; therapeutic footwear (if indicated) and foot care education	Incidence of foot ulcers: IG*: 29.1% (n=44/151), CG^†: 37.3% (n=57/153)
Lavery, et al.¹¹11. Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Armstrong DG, et al. Home Monitoring of Foot Skin Temperatures to Prevent Ulceration. Diabetes Care. 2004 Nov 1;27(11):2642-7. doi: https://doi.org/10.2337/diacare.27.11.2642 https://doi.org/https://doi.org/10.2337/... 2004. United States.	n=85 (IG*: 44, CG^†: 41) Male: 50% Mean age: 55 years old DM2^‡: NR Mean time since the diabetes diagnosis: 14 years Risk of ulcer: 2/3 (IWGDF^§)	Duration: 06 months Outcomes: Proportion of patients in each group who developed foot ulcers, infections, Charcot fractures and amputations	IG*: Handheld infrared thermometer and recording in diary	GC^†: Therapeutic footwear, foot care education, and regular assessment by a podiatrist every 10-12 weeks	Incidence of foot ulcers: IG*: 2% (n=1/44) CG^†: 20% (n=9/41) (seven people presented ulcerations and two had Charcot arthropathies)
Lavery, et al.¹⁷17. Lavery LA, Higgins KR, Lanctot DR, Constantinides GP, Zamorano RG, Athanasiou KA, et al. Preventing Diabetic Foot Ulcer Recurrence in High-Risk Patients: Use of temperature monitoring as a self-assessment tool. Diabetes Care. 2007 Jan 1;30(1):14-20. doi: https://doi.org/10.2337/dc06-1600 https://doi.org/https://doi.org/10.2337/... 2007. United States.	n=173 (IG1: 59, IG2: 56, CG: 58) Male: 54% Mean age: 65 years old DM2^‡: 95% Mean time since the diabetes diagnosis: 13 years Risk of ulcer: 2/3 (IWGDF^§)	Duration: 15 months Outcomes: Proportion of patients in each group who developed foot ulcers	IG1: Handheld infrared thermometer and recording in diary. IG2: Mirror for self-inspection of the feet twice a day and recording in diary	CG^†: Evaluation of the lower limbs (physician), program, therapeutic shoes and evaluation of insoles (podiatrist), pedometer and recording in diary; inspecting the feet daily	Incidence of foot ulcers: IG1: 8.5 (n=5/59) IG2: 30.4 (n=17/56) CG^†: 29.3 (n=17/58)
Skafjeld, et al.²⁸28. The Cochrane Collaboration. Review Manager (RevMan) [Computer program]. Version 5.4. London: The Cochrane Collaboration; 2020 [cited 2021 Aug 23]. Available from: https://training.cochrane.org/online-learning/core-software-cochrane-reviews/revman https://training.cochrane.org/online-lea... 2015. Norway.	n=41 (IG*: 21, CG^†: 20) Male: 56% Mean age: 58 years old DM2^‡: 71% Mean time since the diabetes diagnosis: 18 years Risk of ulcer: 3 (IWGDF^§)	Duration: 12 months Outcomes: Proportion of patients in each group who developed foot ulcers	IG*: Handheld infrared thermometer, recording in diary, theory-based counseling, and pedometer for recording physical activity in the first week of the study	GC^†: Daily foot inspection and recording in diary; use of therapeutic footwear; contacting a nurse if changes were observed	Incidence of foot ulcers: IG*: 39% (n=7/21) CG^†: 50% (n=10/20)

Assessment of Certainty							No. of patients		Effect		Certainty of the evidence	Importance
No. of studies	Study design	Risk of bias	Inconsistency	Indirect evidence	Imprecision	Other considerations	Skin thermometry	Standard health care	Relative (95% CI*)	Absolute (95%CI*)	Certainty of the evidence	Importance
Preventing the incidence of diabetic foot ulcers (Follow-up: Mean of 12.8 months)
4	Randomized clinical trials	Not serious	Not serious	Not serious	Serious^†	None	57/275 (20.7%)	91/272 (33.5%)	RR^‡ 0.53 (From 0.29 to 0.96)	16 minus by 100 (from 24 minus to 1 minus)	ꚚꚚꚚꚚО Moderate	IMPORTANT

[1] Corresponding author:
Açucena Leal de Araújo. E-mail: a.leal09@hotmail.com

Brasil

Brasil

Effect of thermometry on the prevention of diabetic foot ulcers: *

Abstract

Objective:

Method:

Results:

Conclusion: