An interventional study of Foot-related exercises in Diabetes; Neuropathy, Polyneuropathy (Manifestation), sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Sao Paulo General Hospital · Not applicable, Interventional, and Treatment
The main objective of this type 2 hybrid implementation effectiveness trial is to implement a contextually appropriate preventive intervention for 12 weeks face to face group foot and ankle exercises for people with diabetic foot in the primary care of the city of Limeira/SP, through the training of Primary Care workers. The study will monitor the implementation itself and the clinical outcomes: clinical and functional status and quality of life.
The study is a type 2 hybrid implementation effectiveness trial, whose objective is to simultaneously test the clinical intervention and the implementation strategy. The study will take place in 4 phases, the first being pre-implementation, whose objective is to gather information about local characteristics, barriers and facilitators, and constitute the implementation team. During the second phase, the implementation team will be responsible for structuring the actions for the implementation of the intervention, adapting it to the context defined in phase 1, developing strategies for the training of primary care workers. In phase 3, we will implement the intervention either using a software or a booklet for people with diabetes and we will monitor the participants' diabetes-related, functional and quality of life outcomes after the 12 weeks of intervention. Reach, adoption and implementation will be evaluated using the RE-AIM tool. In phase 4 - _maintenance - _the municipality will be responsible for maintaining, expanding and improving the changes achieved, promoting the sharing of experience with other public and private institutions, facilitating the diffusion of similar programs. Specifically in the phase 3, a randomized controlled trial will be performed with 356 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no foot exercises) or an intervention group that will perform face to face exercises, supervised by physiotherapists for 12-weeks. The subjects will be evaluated in 2 different times to access the effect of the intervention: baseline and 12 weeks, for all outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy symptoms by Michigan Neuropathy Screening Instrument, (2) range of motion of the ankle and first metatarsophalangeal joint, (3) fuzzy score of the neuropathy severity, (4) Time up and go, (5) hallux and toes strength (by a pressure plate measurement , (6) hallux strength (by the enhanced paper grip test),(7) ulcers and pre-ulcerative lesions and (8) quality of life (EQ-5D). The hypothesis of this study is that the intervention will reduce the symptoms of diabetic neuropathy, increase the strength of the foot muscles, decrease the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy symptoms, as well increase range of motion, functionality and quality of life.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 356 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Non-inclusion Criteria:
Patients in the intervention group will perform face to face foot-related exercises for 12 weeks.
Other: Foot-related exercises
Participants in the control group will not receive any specific intervention in addition to the treatment recommended by the health professionals team (doctors, nurses, podiatrists), which includes pharmacological treatment, and self-care recommendations and foot care by international consensus.
Face to face foot-related exercises, supervised by physiotherapist and based in the specific software (Sistema de Orientação do Pé diabético, SOPED) and or booklet, in addition to self-care recommendations and foot care by international consensus. The maximum duration of a session is 40 min and should be be performed 1-2 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the physiotherapist. The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression.
Also known as: Intervention group
Change From Baseline Diabetic Neuropathy Symptoms at 12-week Instrument
Score of the Michigan Neuropathy Screening Instrument (MNSI). This questionnaire comprises 15 questions about symptoms and events related to leg and foot sensitivity and is administered by the participant himself. The answers are summed to get a total score. The sum of all items results in a score ranging from 0 to 13 (13 represents the worst rating of the neuropathy)
Time frame: 12 weeks
Change From Baseline of the Foot and Ankle range of motion at 12-week
Ankle and first metatarsophalangeal joint will be measured by manual goniometers.
Time frame: 12 weeks
Change From Baseline of the Fuzzy Classification of the Diabetic Neuropathy Severity at 12-week
The fuzzy classification of the diabetic neuropathy severity will be given by the Fuzzy software score developed by the Laboratory of Biomechanics of Movement and Human Posture available free of charge at: http:// www.usp.br/labimph/fuzzy/. It is a decision support system for classification of the diabetic neuropathy. This decision is based on three domains: signs and symptoms extracted from the Michigan Neuropathy Screening Instrument; tactile sensitivity through the number of non-sensible areas using a 10-g monofilament; and vibration sensitivity by vibrating a tuning fork (128Hz) characterized as absent, present or diminished. The software produces a score from 0 to 10 and the higher the score, the more severe the diabetic neuropathy.
Time frame: 12 weeks
Change from baseline of the toes and hallux strength at 12-week
Toes and hallux (summed) strength will be measured by a pressure plate with the subjects pressing down the plataform with toes standing.
Time frame: 12 weeks
Change from baseline of the hallux strength at 12-week
Hallux strength will be measured by the paper grip test using a card where the examiner places it under the participant's hallux, asking the participant to hold it firmly with the hallux. The examiner pulls the card with increasing force while the participant resists
Time frame: 12 weeks
Change From Baseline Time up and go at 12-week
Time spent for the subjects to rise from a standard arm chair, walk to a marker 3 m away, turn, walk back, and sit down again.
Time frame: 12 weeks
Change from baseline of the Quality of life at 12-week
Score of the EQ-5D questionnaire answered by the participants, which is a generic instrument for measuring health-related quality of life that allows generating an index representing the value of an individual's health status.
Time frame: 12 weeks
Change From Baseline of the foot ulcers and pre ulcerative lesions at 12-week
The presence of ulcers or pre-ulcerative lesions will be monitored through photos without identifying the participant. In cases of doubt, there will be a case discussion with a stoma therapist nurse, specialized in wounds on the feet of people with diabetes
Time frame: 12 weeks
Change From Baseline in Disability at 12-Week Instrument
Score of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 12-item version. This questionnaire assesses functioning and disability during the previous 30 days across different aspects of daily life, including cognition, mobility, self-care, getting along with others, life activities, and participation. Participants rate the level of difficulty experienced in 12 activities using a 5-point response scale ranging from no difficulty to extreme difficulty or inability to perform the activity. The responses are scored to obtain an overall functioning and disability score, with higher scores indicating greater disability. Additional questions assess the number of days during the previous 30 days in which difficulties were present, the participant was completely unable to perform usual activities or work, and usual activities or work were reduced because of the health condition.
Time frame: 12 WEEKS
Healthcare Resource Utilization and Direct/Indirect Costs
Assessment of direct and indirect healthcare costs related to treatment. Information is collected via a standardized questionnaire assessing: 1) Public health resource use (SUS): prescribed medications, diagnostic tests, general practitioner and specialist visits, and physiotherapy sessions; 2) Out-of-pocket expenses: private consultations, tests, non-prescribed medications, complementary supplies (dressings/supplements), and healthcare-related transport (public and private); and 3) Indirect costs: paid and unpaid work absenteeism (hours lost due to health reasons) and monthly salary (in BRL) to estimate productivity loss.
Time frame: 12 WEEKS
Reach of the implementation at 12-week
According to the RE-AIM tool, percentage of coverage and representativeness of people with diabetes participating in the intervention. It will be calculated at the individual level by dividing the population reached by the intervention by the total population of people with diabetes eligible for the intervention. Furthermore, the representativeness of this population will be observed based on sociodemographic data and compared to the non-participating group.
Time frame: 12 weeks
Adoption of the implementation
According to the RE-AIM tool, percentage of coverage and representativeness of locations that we will implement (18 clusters) and key actors participating in phase 1 and in the professional training in phase 2. Representativeness of the participating units and professionals will also be considered in the analysis
Time frame: End of phase 1, end of phase 2
Implementation at 12 weeks
According to the RE-AIM tool, fidelity to the initially proposed intervention will be evaluated qualitatively and quantitatively, as well as the adaptations - if carried out, through feedback during the course of implementation and in the final evaluation
Time frame: 12 weeks
Plan to share: No
Ran from Mar 2023 to primary completion in Aug 2026, 41 months.
Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 41 months is above that.
Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.
Completion moved once since we started tracking on Sep 25, 2026: Dec 2026 → Aug 2026, on Nov 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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