Diabetes MellitusNCT07665775
Effectiveness of an Inpatient Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation
An observational study of Diabetes Mellitus and Transfemoral Amputation, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Transfemoral Amputation, Peripheral Arterial Disease
- How many people
- 54 participants
- Where
- 1 siteMexico
- Study dates
- 19 Jun 2026to Sep 2030
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications.
- Participation in the INRLGII inpatient prosthetic rehabilitation program.
- Availability of complete clinical records or willingness to participate in follow-up assessments .
- Signed informed consent.
Who cannot join
- Current prosthesis user before admission to the INRLGII rehabilitation program.
- Bilateral major lower-limb amputation.
- Inability to complete follow-up assessments.
- Withdrawal Criteria
- Incomplete or inconsistent clinical information.
- Loss to follow-up during the 6-month observation period.
- Participant withdrawal of consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra
Mexico City, Mexico City, 14389
About this study
Official title: Effectiveness of an Inpatient Multidisciplinary Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation Treated at a National Rehabilitation Center: An Ambispective Cohort Study
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.
Read the detailed description
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
- Conditions
- Diabetes Mellitus, Transfemoral Amputation, Peripheral Arterial Disease, Vascular Thrombosis
- Keywords
- Transfemoral Amputation, Vascular Amputation, Diabetes Mellitus, Prosthetic Rehabilitation, Lower Limb Amputation, Prosthesis Use, Prosthetic Adherence, Prosthetic Abandonment, Functional Outcomes, Inpatient Rehabilitation, Multidisciplinary Care, Houghton Scale
- Medical subject headings
- Diabetes Mellitus, Peripheral Arterial Disease, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Vascular or Metabolic Transfemoral Amputation Undergoing Inpatient Prosthetic Rehabili | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Prosthesis Use at 6 Months
Functional prosthesis use defined as prosthesis use ≥8 hours per day and a Houghton Scale score ≥9.
Measured: 6 months after hospital discharge.
Secondary outcomes (3)
Houghton Scale Score
Functional mobility and prosthetic use assessed using the Houghton Scale (0-12 points).
Measured: Time Frame: 3 and 6 months after discharge.
Daily Prosthesis Use
Average number of hours per day the prosthesis is used.
Measured: 3 and 6 months after discharge.
Factors Associated With Functional Prosthesis Use
Association between functional use and demographic, clinical, metabolic, and psychosocial variables.
Measured: Baseline, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start19 Jun 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Rehabilitacion
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LAURA PAULINA MUÑOZ VELASCO, Instituto Nacional de Rehabilitacion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665775
- Sponsor's protocol ID
- INRLGII 03/26
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Inpatient Multidisciplinary Rehabilitation and Prosthetic Training Model in Patients With Vascular and Metabolic Transfemoral Amputation Treated at a National Rehabilitation Center: An Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT07665775
- Acronym / sponsor ID
- INRLGII 03/26
- Conditions
- Diabetes Mellitus, Transfemoral Amputation, Peripheral Arterial Disease, Vascular Thrombosis
- Keywords
- Transfemoral Amputation, Vascular Amputation, Diabetes Mellitus, Prosthetic Rehabilitation, Lower Limb Amputation, Prosthesis Use, Prosthetic Adherence, Prosthetic Abandonment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Instituto Nacional de RehabilitacionOther government
- Study start
- 19 Jun 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Vascular or Metabolic Transfemoral Amputation Undergoing Inpatient Prosthetic Rehabili | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Unilateral transfemoral amputation secondary to vascular disease or diabetes-related complications.
- Participation in the INRLGII inpatient prosthetic rehabilitation program.
- Availability of complete clinical records or willingness to participate in follow-up assessments .
- Signed informed consent.
Key exclusion criteria (7 listed)
- Current prosthesis user before admission to the INRLGII rehabilitation program.
- Bilateral major lower-limb amputation.
- Inability to complete follow-up assessments.
- Withdrawal Criteria
- Incomplete or inconsistent clinical information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional Prosthesis Use at 6 Months
Time frame: 6 months after hospital discharge.
Functional prosthesis use defined as prosthesis use ≥8 hours per day and a Houghton Scale score ≥9.
3 secondary outcomes
Houghton Scale Score
Time frame: Time Frame: 3 and 6 months after discharge.
Daily Prosthesis Use
Time frame: 3 and 6 months after discharge.
Factors Associated With Functional Prosthesis Use
Time frame: Baseline, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: 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.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Transfemoral Amputation, run by Instituto Nacional de Rehabilitacion at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LAURA PAULINA Muñoz Velasco, Medical Doctor (+525559991000 ext. 13213, lpmunoz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Prosthesis Use at 6 Months (time frame: 6 months after hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.