NCT03215953

Brief Summary

Offloading is the concept of relieving pressure to help prevent/cure plantar ulcers, especially in diabetic patients. Many forms of offloading are available, with many limitations to apply in clinical practice. In this study, the investigators compare cast shoe with removable walker considering effectiveness, complications, compliance and patient's appreciation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

July 9, 2017

Last Update Submit

July 13, 2020

Conditions

Diabetic Foot Ulcer

Keywords

offloadingplantar pressureDiabetic Foot Ulcerremovable offloading deviceadherence

Outcome Measures

Primary Outcomes (3)

  • Reduction of mean ulcer radius

    Mean ulcer radius is √(area/π)

    6 months

  • Non-severe adverse events related to use of offloading device

    abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed

    6 months

  • Severe adverse events related to use of offloading device

    new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use

    6 months

Secondary Outcomes (5)

  • Adherence

    6 months

  • Perception

    6 months

  • severity of pain

    6 months

  • Mobility

    6 months

  • Lifestyle limitation

    6 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

cast shoe plus standard wound care

Device: cast shoe

Group B

ACTIVE COMPARATOR

removable walker plus standard wound care

Device: removable walker

Interventions

cast shoeDEVICE

ankle-high, custom-made, well-moulded cast shoe

Group A
removable walkerDEVICE

Prefabricated especially designed for relieving load on the foot

Group B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes, loss of protective sensation, forefoot pressure ulcer

You may not qualify if:

  • Ankle/Brachial index less than 0.7, severe infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

RECRUITING

Related Publications (1)

  • Bus SA, Armstrong DG, van Deursen RW, Lewis JE, Caravaggi CF, Cavanagh PR; International Working Group on the Diabetic Foot. IWGDF guidance on footwear and offloading interventions to prevent and heal foot ulcers in patients with diabetes. Diabetes Metab Res Rev. 2016 Jan;32 Suppl 1:25-36. doi: 10.1002/dmrr.2697. No abstract available.

    PMID: 26813614BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Walaa A Khalifa, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad HM AbdEllah, MSc

CONTACT

+201115353591mhmdifferent@gmail.com

Walaa A Khalifa, MD

CONTACT

+201111677728dr.walaaanwar@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2017

First Posted

July 12, 2017

Study Start

February 1, 2019

Primary Completion

August 1, 2020

Study Completion

September 1, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)