Diabetic Foot UlcerNCT03215953
Offloading Interventions for Diabetic Foot Problems in Upper Egypt
A study testing cast shoe and removable walker in people with Diabetic Foot Ulcer, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- cast shoe and removable walker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 1 Sep 2020
- 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
- Diabetes, loss of protective sensation, forefoot pressure ulcer
Who cannot join
- Ankle/Brachial index less than 0.7, severe infection
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, 71515
Mohammad HM AbdEllah, Specialist, +201115353591, mhmdifferent@gmail.com
Walaa A Khalifa, Consultant
About this study
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.
Read the detailed description
Abnormal glucose metabolism gradually impairs sensation in both feet. Impaired sensation leads to recurrent attacks of inflammation "acute Charcot arthritis". Eventually, the foot becomes deformed with abnormal shape of the plantar surface. During walking, both neuropathy and deformities cause abnormal distribution of pressure with some points in the plantar surface having a very high pressure. This high pressure leads to skin ulceration "pressure ulcer". These pressure ulcers tend to be recurrent or chronic as long as the problem of high pressure is not resolved.
Offloading techniques are pressure-relieving interventions that redistribute body weight over the plantar surface. Areas with high pressure which are at high risk of ulceration, are treated to decrease pressure and cure ulcers.
The diabetic foot clinic at Assiut university hospital provides patients with necessary care to avoid the single most fearsome enemy, amputation. This clinic currently provides many offloading options based on expert opinion, and there is an urgent need to have a well-balanced view supported by evidence, considering both the physician and the patient.
The investigators' project is to conduct a series of trials to guide policies concerned with diabetic foot problems, OIDFUA. This study will compare cast shoe with removable walker, as different offloading options to cure diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- cast shoe, removable walker
- Keywords
- offloading, plantar pressure, Diabetic Foot Ulcer, removable offloading device, adherence
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cast shoeDevice
ankle-high, custom-made, well-moulded cast shoe
removable walkerDevice
Prefabricated especially designed for relieving load on the foot
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | cast shoe plus standard wound care Receives: Device: cast shoe |
| Group B | Active comparator | removable walker plus standard wound care Receives: Device: removable walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of mean ulcer radius
Mean ulcer radius is √(area/π)
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (5)
Adherence
patient's subjective estimation of days per week and hours per day wearing the device of the total days/hours
Measured: 6 months
Perception
patient's own opinion regarding his overall appreciation as a visual analogue score
Measured: 6 months
severity of pain
patient's own opinion regarding pain as a visual analogue score
Measured: 6 months
Mobility
patient's own opinion regarding limitation of mobility as visual analogue score
Measured: 6 months
Lifestyle limitation
patient's own opinion regarding how far the device interferes with his daily activities by naming the activities that needed more effort, e.g. bathing, or stopped, e.g. going to work.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Feb 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (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 Assiut UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hasan AbdEllah, Assiut University
- Investigators
- Walaa A Khalifa, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215953
- Sponsor's protocol ID
- OIDFUE001
- Status last verified
- Jul 2020
- First submitted
- 9 Jul 2017
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26813614
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Offloading Interventions for Diabetic Foot Problems in Upper Egypt
- ClinicalTrials.gov ID
- NCT03215953
- Acronym / sponsor ID
- OIDFUE001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- offloading, plantar pressure, Diabetic Foot Ulcer, removable offloading device, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 12 Jul 2017 (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.
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.
Detailed description
Abnormal glucose metabolism gradually impairs sensation in both feet. Impaired sensation leads to recurrent attacks of inflammation "acute Charcot arthritis". Eventually, the foot becomes deformed with abnormal shape of the plantar surface. During walking, both neuropathy and deformities cause abnormal distribution of pressure with some points in the plantar surface having a very high pressure. This high pressure leads to skin ulceration "pressure ulcer". These pressure ulcers tend to be recurrent or chronic as long as the problem of high pressure is not resolved.
Offloading techniques are pressure-relieving interventions that redistribute body weight over the plantar surface. Areas with high pressure which are at high risk of ulceration, are treated to decrease pressure and cure ulcers.
The diabetic foot clinic at Assiut university hospital provides patients with necessary care to avoid the single most fearsome enemy, amputation. This clinic currently provides many offloading options based on expert opinion, and there is an urgent need to have a well-balanced view supported by evidence, considering both the physician and the patient.
The investigators' project is to conduct a series of trials to guide policies concerned with diabetic foot problems, OIDFUA. This study will compare cast shoe with removable walker, as different offloading options to cure diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: cast shoecast shoe plus standard wound care |
| Group B | Active comparator | Device: removable walkerremovable walker plus standard wound care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes, loss of protective sensation, forefoot pressure ulcer
Key exclusion criteria (1 listed)
- Ankle/Brachial index less than 0.7, severe infection
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 |
|---|---|---|
| cast shoeankle-high, custom-made, well-moulded cast shoe | Device | Group A |
| removable walkerPrefabricated especially designed for relieving load on the foot | Device | Group B |
Primary outcome
Reduction of mean ulcer radius
Time frame: 6 months
Mean ulcer radius is √(area/π)
Non-severe adverse events related to use of offloading device
Time frame: 6 months
abrasions, maceration, fungal infection, or falls that the patient relates to device use Non-severe means resolved within two weeks and device use resumed
Severe adverse events related to use of offloading device
Time frame: 6 months
new ulcer, acute Charcot episode, foot infection, or amputation that the patient relates to device use
5 secondary outcomes
Adherence
Time frame: 6 months
Perception
Time frame: 6 months
severity of pain
Time frame: 6 months
Mobility
Time frame: 6 months
Lifestyle limitation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 26813614Bus 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.
- 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.
Walaa A Khalifa, MD principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cast shoe and removable walker in people with Diabetic Foot Ulcer, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 15 Jul 2020. 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 Egypt. 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 Mohammad HM AbdEllah, MSc (+201115353591, mhmdifferent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of mean ulcer radius (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT03215953, 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 15 Jul 2020.