Diabetic Foot Ulcer Clinical Trial
— MYFOOT-COfficial title:
Prevalence of the Appearance of Diabetic Ulcers, After the Manufacture and Adaptation of Personalized Insoles, With Monitoring of Temperature and Plantar Pressure in Diabetic Patients
Diabetes is a serious and chronic disease that affects more than 347 million people in the world. It is the leading cause of death by age and its prevalence is increasing annually throughout the world. Diabetes is a disorder that manifests itself with elevated blood glucose levels that may be the resultof a deficiency in insulin secretion or action, or a combination of both problems. The "Diabetic foot" includes a number of syndromes in which the interaction of the loss of protective sensation by the presence of sensory neuropathy, the change in pressure points due to motor neuropathy, autonomic dysfunction and decreased Blood flow due to peripheral vascular disease can lead to the appearance of injuries or ulcers induced by minor traumas that go "unnoticed." This situation leads to significant morbidity and a high risk of amputation. It can be prevented with the application of prevention programs, based on the early detection of neuropathy, assessment of associated risk factors, along with the application of a structured program of education and treatment of risk factors. PRIMARY OBJECTIVES: 1- Comparison of ulceration rates, decrease in amputation rates in the target population with intervention: LSCI, thermography and creation of personalized insoles versus the control group with assessment, treatment and follow-up, without the intervention of interest in the study. 2- Correlation between changes in perfusion and temperature detected in combination of LSCI and thermography to predict diabetic foot ulcers and the risk of having ulcers. Study Model: Parallel Assignment 1:1 . Patients with inclusion criteria and without exclusion criteria will be randomized into two groups with Randomization with sequence concealment, centralized in computer support. OxMaR (Oxford Minimization and Randomization) After signing the informed consent, the patients will be divided into two groups. Number of Arms 2 Masking: None (Open Label) A-GROUP WITH LSCI, 3D FOOT CREATOR FOLLOW UP B- GROUP WITHOUT LSCI, 3D FOOT CREATOR FOLLOW UP.
Status | Not yet recruiting |
Enrollment | 86 |
Est. completion date | April 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. The sample will include all the people who sign the informed consent. 2. Patients aged between 18 and 80 years. 3. Patients diagnosed with Diabetes Mellitus (more than 5 years from diagnosis), from the Department of Health Elche Hospital General. 4. Patients with Risk Level 2 and 3 according to the International Working Group on the Diabetic Foot - IWGDF. Exclusion Criteria: 1. People who do not give their consent to participate in the study. 2. Patients who have previously had treatment with plantar orthoses or personalice insole. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Esther Soler | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Universidad Miguel Hernandez de Elche |
Ahmed H, Elshaikh T, Abdullah M. Early Diabetic Nephropathy and Retinopathy in Patients with Type 1 Diabetes Mellitus Attending Sudan Childhood Diabetes Centre. J Diabetes Res. 2020 Nov 24;2020:7181383. doi: 10.1155/2020/7181383. eCollection 2020. — View Citation
Bus SA, Armstrong DG, Gooday C, Jarl G, Caravaggi C, Viswanathan V, Lazzarini PA; International Working Group on the Diabetic Foot (IWGDF). Guidelines on offloading foot ulcers in persons with diabetes (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar — View Citation
Bus SA. Innovations in plantar pressure and foot temperature measurements in diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:221-6. doi: 10.1002/dmrr.2760. — View Citation
Clifton T, Khoo TW, Andrawos A, Thomson S, Greenwood JE. Variation of surface temperatures of different ground materials on hot days: Burn risk for the neuropathic foot. Burns. 2016 Mar;42(2):453-6. doi: 10.1016/j.burns.2015.08.026. Epub 2016 Jan 12. — View Citation
Fernando ME, Crowther RG, Lazzarini PA, Yogakanthi S, Sangla KS, Buttner P, Jones R, Golledge J. Plantar pressures are elevated in people with longstanding diabetes-related foot ulcers during follow-up. PLoS One. 2017 Aug 31;12(8):e0181916. doi: 10.1371/j — View Citation
Garcia-Madrid M, Garcia-Alvarez Y, Sanz-Corbalan I, Alvaro-Afonso FJ, Lopez-Moral M, Lazaro-Martinez JL. Predictive value of forefoot plantar pressure to predict reulceration in patients at high risk. Diabetes Res Clin Pract. 2022 Jul;189:109976. doi: 10.1016/j.diabres.2022.109976. Epub 2022 Jun 27. — View Citation
Liu C, van Netten JJ, van Baal JG, Bus SA, van der Heijden F. Automatic detection of diabetic foot complications with infrared thermography by asymmetric analysis. J Biomed Opt. 2015 Feb;20(2):26003. doi: 10.1117/1.JBO.20.2.026003. — View Citation
Lung CW, Wu FL, Liao F, Pu F, Fan Y, Jan YK. Emerging technologies for the prevention and management of diabetic foot ulcers. J Tissue Viability. 2020 May;29(2):61-68. doi: 10.1016/j.jtv.2020.03.003. Epub 2020 Mar 17. — View Citation
Norhammar A, Malmberg K, Diderholm E, Lagerqvist B, Lindahl B, Ryden L, Wallentin L. Diabetes mellitus: the major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revasculari — View Citation
Pallin JA, Van Netten JJ, Kearney PM, Dinneen SF, Buckley CM. Do we screen, examine or assess to identify the "at-risk" foot in diabetes-time for agreed terms and definitions? Diabet Med. 2023 Jan;40(1):e14976. doi: 10.1111/dme.14976. Epub 2022 Oct 26. No abstract available. — View Citation
Sibbald RG, Mufti A, Armstrong DG. Infrared skin thermometry: an underutilized cost-effective tool for routine wound care practice and patient high-risk diabetic foot self-monitoring. Adv Skin Wound Care. 2015 Jan;28(1):37-44; quiz 45-6. doi: 10.1097/01.ASW.0000458991.58947.6b. — View Citation
Valk GD, Kriegsman DM, Assendelft WJ. Patient education for preventing diabetic foot ulceration. A systematic review. Endocrinol Metab Clin North Am. 2002 Sep;31(3):633-58. doi: 10.1016/s0889-8529(02)00021-x. — View Citation
van Netten JJ, Price PE, Lavery LA, Monteiro-Soares M, Rasmussen A, Jubiz Y, Bus SA; International Working Group on the Diabetic Foot. Prevention of foot ulcers in the at-risk patient with diabetes: a systematic review. Diabetes Metab Res Rev. 2016 Jan;32 — View Citation
Yang L, Wu Y, Zhou C, Xie C, Jiang Y, Wang R, Ye X. Diabetic foot ulcer risk assessment and prevention in patients with diabetes: a best practice implementation project. JBI Evid Implement. 2022 Dec 1;20(4):269-279. doi: 10.1097/XEB.0000000000000306. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ankle-brachial index (ABI) | The ankle-brachial index (ABI). The test compares the blood pressure in the ankle and the blood pressure in the arm. The provider uses a blood pressure cuff and an ultrasound device.
The normal result of the ABI is 1.00 or more. If you have an ABI of less than 0.90 at rest, you probably have PAD. An ABI of less than 0.40 is a sign of severe PAD. If there are problems with the arteries in your ankle, your provider may measure your toe-brachial index (BPI), which measures blood pressure in your big toe. A BDI of less than 0.7 is abnormal. |
15 minutes | |
Primary | Laser speckle contrast imaging technique (LSCI) that measures the blood flow | the Laser Speckle Contrast Imaging (LSCI) technology, also known as the Laser Speckle Imaging system (LSI), which is non-invasive with non-contact, high time resolution, high spatial resolution, and full-field rapid imaging. It provides real-time dynamic blood flow monitoring and recording methods for research in life sciences | 15 minutes | |
Primary | Design the 3D model of the insole | Custom 3D-printed orthotic insoles. Translate foot measurement data into 3D-printed orthotics that fit the individual's foot perfectly. | 2 day | |
Primary | Diabetic foot exam:neurologic examination-PAINFUL AND TACTILE SENSITIVITY | The patient will be placed in supine position.
The tests will be performed alternating the exploration of painful and tactile sensitivity until completing all the sections. Execution: Instruct the patient to close their eyes. Alternate touches with the pointed object and cotton on the planting areas (A-F) and on the dorsal areas (G-I) indicated in the drawings. You have to wait a minimum of 2 seconds between touches to avoid the summation effect. Do not perform the scan in areas with hyperkeratosis or calluses. Interpretation - Yes (Painful): , when the patient communicates to the clinician the sensation of puncture in the explored area. |
15 minutes | |
Primary | Diabetic foot exam:neurologic examination-VIBRATORY SENSITIVITY | The patient will be placed in supine position.
The tests will be performed alternating the exploration of painful and tactile sensitivity until completing all the sections. Instruct the patient to close their eyes. Alternate touches with the pointed object and cotton on the planting areas (A-F) and on the dorsal areas (G-I) indicated in the drawings. You have to wait a minimum of 2 seconds between touches to avoid the summation effect. Do not perform the scan in areas with hyperkeratosis or calluses. Interpretation No (Painful): When the patient does not communicate to the clinician the sensation of puncture in the explored area. No (Tactyl): When the patient does not communicate to the clinician the sensation of contact in the explored area. |
15 minutes | |
Primary | Diabetic foot exam:neurologic examination-THERMAL SENSITIVITY | Previous Considerations:
This test may be skipped if the pain sensitivity is normal. Previously, both stimuli must be performed in another uncommitted area of the body. 2 test tubes will be prepared with water at two different temperatures: 1 tube called 'cold' with the water at a temperature below 15ºC and 1 tube called 'hot' with the water at a temperature above 40ºC. Execution: Instruct the patient to close their eyes. The 'hot' and 'cold' tube will be applied to the skin of the dorsal area (G-I) randomly. Ask the patient if the sensation perceived after the application of a tube (cold or hot), is of higher or lower temperature than the tube previously applied. Randomly toggle between the G-I zones marked on the chart. Interpretation: Cold: When the patient communicates to the clinician the feeling of cold. Hot: When the patient does not communicate to the clinician the sensation of heat. |
15 minutes | |
Primary | Diabetic foot exam:neurologic examination-PROTECTIVE SENSITIVITY | Execution:
Instruct the patient to close their eyes. Apply the monofilament randomly on the A-F zones of the sole of the foot and at the points of the dorsal zone G-I, pressing until the filament bends. Hyperkeratostic areas should be avoided. Interpretation: Yes: When the patient communicates to the clinician the sensation of the stimulus. No: When the patient does not communicate to the clinician the sensation of the stimulus. |
15 minutes | |
Primary | Diabetic foot exam:neurologic examination- ARTHROKINETIC SENSITIVITY | Execution:
The test must be performed previously on a finger of the hand, so that the patient understands the performance of the test. The patient will close the eyes and move the distal phalanges of the 1st, 3rd and 5th toes, a few degrees towards dosal flexion and plantar flexion. The patient will be asked in which direction the joint has moved. Interpretation: Yes: When the patient correctly communicates the direction of movement. No: When the patient does not communicate correctly the direction of movement. |
15 minutes | |
Primary | Diabetic foot exam: musculoskeletal examination | A method of evaluating muscle strength is the Medical Research Council Manual Muscle Testing Scale.This method involves testing key muscles from the upper and lower extremities against gravity and the examiner's resistance and grading the patient's strength on a 0 to 5 scale.
Hallux Valgus: The test will be performed by visualization. Interpretation: It will be evaluated following the criteria of the Manchester Scale for the graduation of the Hallux Abductus Valgus (Garrow AP, Papageorgiou A, Silman AJ, Thomas E, Jayson MI, Macfarlane GJ. The grading of hallux valgus. The Manchester Scale. J Am Podiatr Med Assoc. 2001;91(2):74-78. doi:10.7547/87507315-91-2-74) in; A: Normal. B: Mild. C: Moderate. D: Severe Hallux Extensus. Hallux Flexus. https://wtcs.pressbooks.pub/nursingskills/chapter/13-4-musculoskeletal-assessment/ |
10 minutes | |
Primary | Diabetic foot exam: dermatologic examination | All the test will be performed by visualization. - Hyperkeratosis.-Ulcer shall be considered to be the total loss of the epidermis.-Onychocryptosis shall be considered to be the incrustation of the lateral edges of the nail.-Onychogriphosis shall be considered to be the thickening of the nail plate with a hyperkeratotic.-Onychomycosis is considered to be any nail infection caused by any fungus. -Hyperhidrosis will be considered the excessive increase in sweating of the feet.-Anhidrosis will be considered to be the absence or decrease of sweating of the feet.-Signs of infection will be considered to be the presence of red, hot, sensitive and indurated skin with the presence of pain in the area. Dermatomycosis.-A circumscribed dermatological lesion greater than 1 cm and with liquid content.-Hematoma will be considered to be a hemorrhage circumscribed in the skin.-A linear disruption of the stratum corneum shall be considered a fissure. | 10 minutes | |
Secondary | Diabetes Self-Care | A psychometric analysis of the Self-Care Inventory-revised with adults. TEST: Self-Care Inventory-revised (SCI-R) The SCI-R is a brief, psychometrically sound measure of perceptions of adherence to recommended diabetes self-care behaviors of adults with type 1 or type 2 diabetes.
Weinger, K., Butler, H. A., Welch, G. W., & La Greca, A. M. (2005). Measuring diabetes self-care: a psychometric analysis of the Self-Care Inventory-Revised with adults. Diabetes care, 28(6), 1346-1352. https://doi.org/10.2337/diacare.28.6.1346 |
10 minutes |
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