Diabetic Foot UlcerNCT04117269
External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
A study testing External shoe lift in people with Diabetic Foot Ulcer and Peripheral Neuropathy, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Peripheral Neuropathy, Treatment Adherence and Compliance
- What is being tested?
- External shoe lift
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2019to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Plantar diabetic foot ulcer.
- Wagner I and II classification.
- Ulcer area between 1-30 cm square centimeters.
- HbA1c values in the last three months below 11%
- Ankle brachial Index (ABI) value > 0.5.
Who cannot join
- Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline.
- Presence of foot ulcer in both feet.
- Presence of soft tissue infection.
- Osteomyelitis suspicion.
- Peripheral neuropathy due to different causes than diabetes.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Diabetic foot Unit Complutense University
Madrid, 28040
Raúl Juan Molines Barroso, Phd, 639059104 ext. +34, rauljmolines@hotmail.com
José Luis Lázaro Martínez, Phd
About this study
Official title: Clinical Efficacy of an External Shoe Lift in the Contralateral Limb to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.
- Being tested
- External shoe lift
- Medical subject headings
- Diabetic Foot, Peripheral Nervous System Diseases, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External shoe liftDevice
Height compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously
| Study group | Role | What they receive |
|---|---|---|
| External shoe lift | Experimental | Those patients allocated in the experimental group will be supplemented with a external shoe lift in the contralateral limb in their conventional shoes to compensate the differences with the affected foot (using a offloading device to active ulcer). Receives: Device: External shoe lift |
| Standard of care | No intervention | Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of diabetic foot ulcers healed
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Measured: 12 weeks
Secondary outcomes (3)
Percentage of diabetic foot ulcers healed
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Measured: 20 weeks
Adherence to offloading device
Two pedometer will be used (one inside the vendaje and the other into the offloading device)
Measured: 3 days
Time to healing
Time in weeks of diabetic foot ulcer healing
Measured: 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start15 Nov 2019
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Juan Molines Barroso, Phd, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117269
- Sponsor's protocol ID
- 19/337-E
- Status last verified
- May 2022
- First submitted
- 3 Oct 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Moral M, Garcia-Madrid M, Molines-Barroso RJ, Sanz-Corbalan I, Tardaguila-Garcia A, Lazaro-Martinez JL. Clinical Efficacy of a Contralateral Shoe Lift in Patients with Diabetic Foot Ulcers and Induced Limb-Length Discrepancies: A Randomized Controlled Trial. Adv Wound Care (New Rochelle). 2025 May;14(5):251-259. doi: 10.1089/wound.2024.0151. Epub 2024 Oct 24.
PubMed 39447017
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of an External Shoe Lift in the Contralateral Limb to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04117269
- Acronym / sponsor ID
- 19/337-E
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 7 Oct 2019 (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.
Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External shoe lift | Experimental | Device: External shoe liftThose patients allocated in the experimental group will be supplemented with a external shoe lift in the contralateral limb in their conventional shoes to compensate the differences with the affected foot (using a offloading device to active ulcer). |
| Standard of care | No intervention | –Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Plantar diabetic foot ulcer.
- Wagner I and II classification.
- Ulcer area between 1-30 cm square centimeters.
- HbA1c values in the last three months below 11%
- Ankle brachial Index (ABI) value > 0.5.
Key exclusion criteria (5 listed)
- Diagnosis of Critical Limb Ischaemia definid by TASCC II guideline.
- Presence of foot ulcer in both feet.
- Presence of soft tissue infection.
- Osteomyelitis suspicion.
- Peripheral neuropathy due to different causes than diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External shoe liftHeight compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously | Device | External shoe lift |
Primary outcome
Percentage of diabetic foot ulcers healed
Time frame: 12 weeks
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
3 secondary outcomes
Percentage of diabetic foot ulcers healed
Time frame: 20 weeks
Adherence to offloading device
Time frame: 3 days
Time to healing
Time frame: 30 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Derived from this study: PubMed 39447017Lopez-Moral M, Garcia-Madrid M, Molines-Barroso RJ, Sanz-Corbalan I, Tardaguila-Garcia A, Lazaro-Martinez JL. Clinical Efficacy of a Contralateral Shoe Lift in Patients with Diabetic Foot Ulcers and Induced Limb-Length Discrepancies: A Randomized Controlled Trial. Adv Wound Care (New Rochelle). 2025 May;14(5):251-259. doi: 10.1089/wound.2024.0151. Epub 2024 Oct 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External shoe lift in people with Diabetic Foot Ulcer and Peripheral Neuropathy, run by Universidad Complutense de Madrid at 1 site in Spain.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raúl Juan Molines Barroso, Phd (639059104 ext. +34, rauljmolines@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of diabetic foot ulcers healed (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117269, which also lists 1 linked publication.
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 18 May 2022.