search
Back to results

External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcer, Peripheral Neuropathy, Treatment Adherence and Compliance

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
External shoe lift
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Diabetic foot Unit Complutense UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

External shoe lift

Standard of care

Arm Description

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).

Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment.

Outcomes

Primary Outcome Measures

Percentage of diabetic foot ulcers healed
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate

Secondary Outcome Measures

Percentage of diabetic foot ulcers healed
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Adherence to offloading device
Two pedometer will be used (one inside the vendaje and the other into the offloading device)
Time to healing
Time in weeks of diabetic foot ulcer healing

Full Information

First Posted
October 3, 2019
Last Updated
May 17, 2022
Sponsor
Universidad Complutense de Madrid
search

1. Study Identification

Unique Protocol Identification Number
NCT04117269
Brief Title
External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
Official Title
Clinical Efficacy of an External Shoe Lift in the Contralateral Limb to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 healing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer, Peripheral Neuropathy, Treatment Adherence and Compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
External shoe lift
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Those patients allocated in the control group will not be supplemented, they will be treated with a standard of care treatment.
Intervention Type
Device
Intervention Name(s)
External shoe lift
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of diabetic foot ulcers healed
Description
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Percentage of diabetic foot ulcers healed
Description
Evaluated by the same clinicians, defined as 100% of epithelialization in absence of exudate
Time Frame
20 weeks
Title
Adherence to offloading device
Description
Two pedometer will be used (one inside the vendaje and the other into the offloading device)
Time Frame
3 days
Title
Time to healing
Description
Time in weeks of diabetic foot ulcer healing
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raúl Juan Molines Barroso, Phd
Phone
639059104
Ext
+34
Email
rauljmolines@hotmail.com
Facility Information:
Facility Name
Diabetic foot Unit Complutense University
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raúl Juan Molines Barroso, Phd
Phone
639059104
Ext
+34
Email
rauljmolines@hotmail.com
First Name & Middle Initial & Last Name & Degree
José Luis Lázaro Martínez, Phd
First Name & Middle Initial & Last Name & Degree
Marta García-Madrid Martín de Almagro, Phd
First Name & Middle Initial & Last Name & Degree
Mateo López Moral, Phd

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers

We'll reach out to this number within 24 hrs