An observational study in Diabetes Mellitus, Transfemoral Amputation and Peripheral Arterial Disease, sponsored by Instituto Nacional de Rehabilitacion. Not yet recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Instituto Nacional de Rehabilitacion · Observational
Patients with vascular and metabolic transfemoral amputations experience substantial functional limitations and high rates of prosthetic abandonment. Although multidisciplinary inpatient rehabilitation programs have been associated with improved outcomes, evidence regarding their effectiveness in low- and middle-income countries remains limited.
This study aims to evaluate the effectiveness of an inpatient rehabilitation and prosthetic training model implemented at the National Institute of Rehabilitation "Luis Guillermo Ibarra Ibarra" (INRLGII), Mexico. An ambispective cohort design will be used, including a retrospective review of patients treated between 2013 and 2025 and a prospective cohort enrolled between 2026 and 2029.
The primary objective is to determine the proportion of patients who achieve functional prosthesis use after hospital discharge. Secondary objectives include identifying clinical, metabolic, functional, and psychosocial factors associated with successful prosthetic use, adherence, and abandonment.
Background
Diabetes mellitus and peripheral vascular disease are major causes of lower-limb amputation worldwide. Transfemoral amputation is associated with substantial disability, increased energy expenditure during ambulation, reduced mobility, and decreased quality of life. Despite advances in prosthetic technology, long-term prosthetic use remains challenging, with reported abandonment rates ranging from 30% to 60%.
The National Institute of Rehabilitation "Luis Guillermo Ibarra Ibarra" (INRLGII) has developed a multidisciplinary inpatient rehabilitation and prosthetic training model for patients with vascular and metabolic amputations. The program integrates rehabilitacion medicine, physical therapy, occupational therapy, psychology, cardiopulmonary evaluation, biomedical engineering, and prosthetic fabrication in a coordinated inpatient setting.
Although international evidence suggests that inpatient multidisciplinary rehabilitation improves functional outcomes and prosthetic success, no institutional or national studies have systematically evaluated the effectiveness of this model in Mexican patients with vascular and metabolic transfemoral amputation.
Objective
To evaluate the effectiveness of an inpatient multidisciplinary rehabilitation and prosthetic training model in patients with unilateral transfemoral amputation of vascular or metabolic etiology.
Study Design
This is an observational, longitudinal, ambispective cohort study.
The retrospective phase will include patients treated between 2013 and 2025 through review of electronic medical records.
The prospective phase will include consecutive patients enrolled between 2026 and 2029. Functional prosthesis use will be assessed at 3 and 6 months after discharge using the Houghton Scale and structured recording of daily prosthesis use.
Hypothesis
The inpatient rehabilitation and prosthetic training model is associated with a higher proportion of functional prosthesis use at 6 months compared with rates reported in the international literature for vascular and metabolic transfemoral amputees
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 54 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Instituto Nacional de Rehabilitacion is the lead sponsor of 19 studies on the registry; 7 are open to participants now.
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Adult patients (≥18 years) with unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications who are treated through the inpatient prosthetic rehabilitation program at the National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra (INRLGII), Mexico.
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Exclusion Criteria:
Withdrawal Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications who participate in the inpatient prosthetic rehabilitation program at the National Institute of Rehabilitation Luis Guillermo Ibarra Ibarra (INRLGII). Participants will be evaluated for functional prosthesis use, adherence, and factors associated with successful prosthetic rehabilitation.
Functional Prosthesis Use at 6 Months
Functional prosthesis use defined as prosthesis use ≥8 hours per day and a Houghton Scale score ≥9.
Time frame: 6 months after hospital discharge.
Houghton Scale Score
Functional mobility and prosthetic use assessed using the Houghton Scale (0-12 points).
Time frame: Time Frame: 3 and 6 months after discharge.
Daily Prosthesis Use
Average number of hours per day the prosthesis is used.
Time frame: 3 and 6 months after discharge.
Factors Associated With Functional Prosthesis Use
Association between functional use and demographic, clinical, metabolic, and psychosocial variables.
Time frame: Baseline, 3 months, and 6 months.
Plan to share: No — Individual participant data will not be shared because the dataset contains sensitive clinical information from a relatively small patient population, which may increase the risk of participant re-identification despite de-identification procedures. Data will be used exclusively for the purposes approved by the institutional ethics and research committees.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Rehabilitacion