Prevalence of the Appearance of Diabetic Ulcers in Patients With 3D Insole and LSCI.

NCT05843929 | Unknown

• 1 other identifier: MYFOOT-C-AB/2023
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabete Type 2; Diabetic Foot; Neuropathy, Diabetic; Vascular Disease, Peripheral; Diabetic Foot Ulcer

Keywords

Diabete Type 2; Diabetic Foot; Neuropathy, Diabetic; Vascular Disease, Peripheral; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• Diabetic foot exam:neurologic examination-THERMAL SENSITIVITY

  1. 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. 2. 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. 3. 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

• Diabetic foot exam:neurologic examination-PROTECTIVE SENSITIVITY

  1. 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. 2. 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

• Diabetic foot exam:neurologic examination- ARTHROKINETIC SENSITIVITY

  1. 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. 2. 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

• 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

• 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 Outcomes (1)

• Diabetes Self-Care

  10 minutes

Study Arms (2)

Group with Laser speckle contrast imaging technique (LSCI) and 3D foot creator use

EXPERIMENTAL

The proposed solution is based on the process synthetized in, and hereafter described: * A technician delivers a service at the home of the diabetic patient, who may be subject to different risk of ulcer, with the aim to analyse his/her foot through an integrated set of measurement technologies, based on: * the piezoelectric insole that replaces missing pain sensation; * Laser speckle contrast imaging technique (LSCI) that measures the blood flow; * the multi points temperature device. * Data collected by the technician are sent via internet to the reference Hospital or Primary Care Unit where a specialist physician evaluates the acquired information; * On the basis of the clinical evaluation and doctor's report on points of foot sensitivity, a 3D model of the foot is created and used by the chiropodist; * Using the 3D model of the foot, the chiropodist uses a 3D Editor to design the 3D Model of the insole

Diagnostic Test: LSCI

Group not use laser speckle contrast imaging technique (LSCI) and not use 3D foot creator use

NO INTERVENTION

* The patients of this group will be visited in the hospital: * An assessment of the patient's risk of presenting problems due to diabetic foot will be carried out. * In this group, the control measures will be established within the usual practice in consultations. * No visits will be made to the patient's home. You will always visit the doctor's office. * If any problem is detected, the patient will be visited by health personnel and the usual treatments in these patients at present will be applied.

Interventions

LSCI DIAGNOSTIC_TEST

1. A technician delivers a service at the home of the patient, who may be subject to different risk of ulcer, with the aim to analyse his/her foot through an integrated set of measurement technologies, based on:a-the piezoelectric insole that replaces missing pain sensation;b- Laser speckle contrast imaging technique (LSCI) that measures the blood flow;c- the multi points temperature device. 2. Data collected by the technician are sent via internet 3. On the basis of the clinical evaluation and doctor's report on points of foot sensitivity, a 3D model of the foot is created and used by the chiropodist; 4. Using the 3D model of the foot, the chiropodist uses a 3D Editor to design the 3D Model of the insole to enable the production of a tailored insole for the patient shoes 5. The final manufactured insole is then delivered to the patient; 6. A check survey is periodically carried out by the technician to scan the diabetic foot status progress

Also known as: 3D FOOT INSOLE

Group with Laser speckle contrast imaging technique (LSCI) and 3D foot creator use

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The sample will include all the people who sign the informed consent.
• Patients aged between 18 and 80 years.
• Patients diagnosed with Diabetes Mellitus (more than 5 years from diagnosis), from the Department of Health Elche Hospital General.
• Patients with Risk Level 2 and 3 according to the International Working Group on the Diabetic Foot - IWGDF.

You may not qualify if:

• People who do not give their consent to participate in the study.
• Patients who have previously had treatment with plantar orthoses or personalice insole.

Sponsors & Collaborators

• Esther Soler: lead
• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: collaborator
• Universidad Miguel Hernandez de Elche: collaborator

Related Publications (14)

• 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.

  PMID: 25502975 BACKGROUND

• 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.

  PMID: 36251428 BACKGROUND

• 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.

  PMID: 35772587 BACKGROUND

• 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.

  PMID: 33299891 RESULT

• 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 revascularization. J Am Coll Cardiol. 2004 Feb 18;43(4):585-91. doi: 10.1016/j.jacc.2003.08.050.

  PMID: 14975468 RESULT

• 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.

  PMID: 12227125 RESULT

• 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;36 Suppl 1:e3274. doi: 10.1002/dmrr.3274.

  PMID: 32176441 RESULT

• 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.

  PMID: 26467347 RESULT

• 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.

  PMID: 25671671 RESULT

• 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 Suppl 1:84-98. doi: 10.1002/dmrr.2701.

  PMID: 26340966 RESULT

• 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.

  PMID: 26797153 RESULT

• 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.

  PMID: 32197948 RESULT

• 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/journal.pone.0181916. eCollection 2017.

  PMID: 28859075 RESULT

• 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.

  PMID: 35013076 RESULT

Related Links

• EUROPA INFORMED CONSENT INFORMATION
• IWGDF GUIDELINES

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Foot; Diabetic Neuropathies; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• ESTHER SOLER, BSN

  CGE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ESTHER SOLER, BSN

CONTACT

+034 966 61 69 00; soler_estcli@gva.es

ESTHER SOLER, BSN

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Randomized controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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. 1. Group with Laser speckle contrast imaging technique (LSDI), 3D foot creator 2. Group not LSCI, 3D foot Creator

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: May 6, 2023
• Study Start: February 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share