Charcot Joint of FootNCT04668755
Effect of CROW 3d Printed Sole on Charcot Foot Ulcer
A study testing Charcot Restraint Orthotic Walker 3d printed sole and Generic Charcot Restraint orthotic walker in people with Charcot Joint of Foot, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to evaluate the therapeutic effect of the Charcot Restraint Orthotic Walker three-dimensional printed sole on Charcot foot ulcer healing. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Charcot Joint of Foot
- What is being tested?
- Charcot Restraint Orthotic Walker 3d printed sole and Generic Charcot Restraint orthotic walker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2020to 1 Jun 2021
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject selection will be according to the following criteria: • The patient's ages will range from 45 to 65 years.
- Both sexes will be included in the study.
- Informed consent for participation in this study will be obtained in writing from all patients.
Who cannot join
- The potential participants will be excluded if they meet one of the following criteria:
- Preceding surgical procedure on affected foot.
- Patients on hemodialysis.
- Patients who had any pathological conditions which may affect the results of the study as active malignancy, osteomyelitis and pes planus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Charcot Restraint Orthotic Walker Three-Dimensional Printed Sole On Charcot Foot Ulcer
The purpose of the study is to evaluate the therapeutic effect of the Charcot Restraint Orthotic Walker three-dimensional printed sole on Charcot foot ulcer healing.
Read the detailed description
Foot ulcerations, Charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. Consequently, foot disorders are leading causes of hospitalization for persons with peripheral neuropathy. Although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management, The reduction of pressure to the Charcot foot ulcer is essential to treatment. Proper off-loading and pressure reduction prevents further trauma and promotes healing. This is particularly important in the peripheral neuropathy patient with decreased or absent sensation in the lower extremities. Furthermore, recent studies provide evidence that minor trauma (eg, repetitive stress, shoe pressure) plays a major role in the causal pathway to ulceration.
- Off-loading approaches that deal with Charcot neuroarthropathy will decrease the significant psychological, social and functional impact on individuals.
- The need of this study is developed from the lack of controlled studies that reported the therapeutic effect of Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer.
- So the present study is designed to evaluate the Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer. Furthermore, the current study may help physical therapist, physicians, and clinicians to organize a protocol of treatment that would be safe, simple and economic for treating patients with Charcot neuroarthropathy.
- Conditions
- Charcot Joint of Foot
- Being tested
- Charcot Restraint Orthotic Walker 3d printed sole, Generic Charcot Restraint orthotic walker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Charcot Restraint Orthotic Walker 3d printed soleDevice
The Charcot Restraint Orthotic Walker (CROW) consists of anterior and posterior shells creating a total contact environment based on a rocker sole. the sole is manufactured by 3d printed Metamaterial .
Manufacture of the 3d printed sole of the CROW paths through two stages ;Computer aided designing (CAD) and computer aided manufacturing (CAM) .
Generic Charcot Restraint orthotic walkerDevice
It is a clamshell (two piece) design that provides complete/total contact over the shin, calf and foot. The CROW reduces all motion in the ankle and foot to reduce potential for further injury. It is fully padded on the inside, and the bottom is covered with a material similar to shoe soling. It is not worn with a shoe.
| Study group | Role | What they receive |
|---|---|---|
| Charcot Restraint Orthotic Walker 3d printed sole | Active comparator | the group fit with Charcot Restraint Orthotic Walker 3d printed sole for 12 week. the protocol of gait analysis testing starts with a reacclimation period during which the subject walked usual freely walking across the path for a duration of four minutes and then the testing session data collection done by four acceptable force platform strikes for the feet fitted with the CROW. Receives: Device: Charcot Restraint Orthotic Walker 3d printed sole |
| Generic Charcot Restraint orthotic walker | Active comparator | the group fit with Generic Charcot Restraint Orthotic Walker for 12 week.the protocol of gait analysis testing starts with a reacclimation period during which the subject walked usual freely walking across the path for a duration of four minutes and then the testing session data collection done by four acceptable force platform strikes for the feet fitted with the CROW. Receives: Device: Generic Charcot Restraint orthotic walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force platform to measure peak vertical ground reaction plantar force
Plantar vertical ground reaction force obtained at a rate of 100 Hz measured by Nintendo Wii Balance Board (WBB Nintendo Co. Ltd. Kyoto, Japan) through a four strain gauge sensors (uniaxial vertical force transducers) located at the corners of the board with a usable size of 45 x 26.5 cm were used for data collection; wirelessly via Bluetooth by using third party software illustrates the peak vertical force parameter.
Measured: Pre-intervention
Force platform to measure peak vertical ground reaction plantar force
Plantar vertical ground reaction force obtained at a rate of 100 Hz measured by Nintendo Wii Balance Board WBB (Nintendo Co. Ltd. Kyoto, Japan) through a four strain gauge sensors (uniaxial vertical force transducers) located at the corners of the board with a usable size of 45 x 26.5 cm were used for data collection; wirelessly via Bluetooth by using third party software illustrates the peak vertical force parameter
Measured: Three months post-intervention
Secondary outcomes (2)
Wound Surface area using ImageJ software
The patient is positioned in a comfortable position with exposure of the wound. A ruler as a reference is place directly flat and attach to the skin around the wound area. A photographs were taken including the reference ruler in the images that is captured for the whole wound margins taking in consideration standardization the same angle of capture in the flat mid foot ulcers, but in case of ulcers extend to foot edge, a sterilized transparent grid film (1x1 cm) attached flat on the ulcer then wound margins traced on the transparent grid film and then photographed, then the captured photographs is exported to the computer to be visualized with ImageJ 1.52t software. Surface area measurement of wound margins are traced by the same investigator to establish reliability of measurements
Measured: Pre-intervention
Wound Surface area using ImageJ software
The patient is positioned in a comfortable position with exposure of the wound. A ruler as a reference is place directly flat and attach to the skin around the wound area. A photographs were taken including the reference ruler in the images that is captured for the whole wound margins taking in consideration standardization the same angle of capture in the flat mid foot ulcers, but in case of ulcers extend to foot edge, a sterilized transparent grid film (1x1 cm) attached flat on the ulcer then wound margins traced on the transparent grid film and then photographed, then the captured photographs is exported to the computer to be visualized with ImageJ 1.52t software. Surface area measurement of wound margins are traced by the same investigator to establish reliability of measurements
Measured: Three months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start5 Dec 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcot Joint of FootStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- * Sixty patients with Charcot neuroarthropathic foot ulcer (Chronic stage) recruited in the study. * Patients divided in to two equal groups in number: * Group A (Study group): This group compose of 30 patients whom they received the same standard medical treatment as group B in addition fitting with Charcot Restraint Orthotic Walker 3d printed sole for 12 weeks. \- Group B (Control group): This group compose of 30 patients whom they received the standard medical treatment in addition fitting with Generic Charcot Restraint Orthotic Walker for 12 weeks.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Amin Elessawy, Cairo University
- Investigators
- Amal M Abd El Baky, PhD, Study director, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668755
- Sponsor's protocol ID
- 012/002367
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2020
- Last updated
- 25 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Charcot Restraint Orthotic Walker Three-Dimensional Printed Sole On Charcot Foot Ulcer
- ClinicalTrials.gov ID
- NCT04668755
- Acronym / sponsor ID
- 012/002367
- Conditions
- Charcot Joint of Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 16 Dec 2020 (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.
The purpose of the study is to evaluate the therapeutic effect of the Charcot Restraint Orthotic Walker three-dimensional printed sole on Charcot foot ulcer healing.
Detailed description
Foot ulcerations, Charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. Consequently, foot disorders are leading causes of hospitalization for persons with peripheral neuropathy. Although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management, The reduction of pressure to the Charcot foot ulcer is essential to treatment. Proper off-loading and pressure reduction prevents further trauma and promotes healing. This is particularly important in the peripheral neuropathy patient with decreased or absent sensation in the lower extremities. Furthermore, recent studies provide evidence that minor trauma (eg, repetitive stress, shoe pressure) plays a major role in the causal pathway to ulceration.
- Off-loading approaches that deal with Charcot neuroarthropathy will decrease the significant psychological, social and functional impact on individuals.
- The need of this study is developed from the lack of controlled studies that reported the therapeutic effect of Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer.
- So the present study is designed to evaluate the Charcot Restraint Orthotic Walker 3d printed sole on Charcot foot ulcer. Furthermore, the current study may help physical therapist, physicians, and clinicians to organize a protocol of treatment that would be safe, simple and economic for treating patients with Charcot neuroarthropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- * Sixty patients with Charcot neuroarthropathic foot ulcer (Chronic stage) recruited in the study. * Patients divided in to two equal groups in number: * Group A (Study group): This group compose of 30 patients whom they received the same standard medical treatment as group B in addition fitting with Charcot Restraint Orthotic Walker 3d printed sole for 12 weeks. - Group B (Control group): This group compose of 30 patients whom they received the standard medical treatment in addition fitting with Generic Charcot Restraint Orthotic Walker for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Charcot Restraint Orthotic Walker 3d printed sole | Active comparator | Device: Charcot Restraint Orthotic Walker 3d printed solethe group fit with Charcot Restraint Orthotic Walker 3d printed sole for 12 week. the protocol of gait analysis testing starts with a reacclimation period during which the subject walked usual freely walking across the path for a duration of four minutes and then the testing session data collection done by four acceptable force platform strikes for the feet fitted with the CROW. |
| Generic Charcot Restraint orthotic walker | Active comparator | Device: Generic Charcot Restraint orthotic walkerthe group fit with Generic Charcot Restraint Orthotic Walker for 12 week.the protocol of gait analysis testing starts with a reacclimation period during which the subject walked usual freely walking across the path for a duration of four minutes and then the testing session data collection done by four acceptable force platform strikes for the feet fitted with the CROW. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject selection will be according to the following criteria: • The patient's ages will range from 45 to 65 years.
Key exclusion criteria (4 listed)
- The potential participants will be excluded if they meet one of the following criteria:
- Preceding surgical procedure on affected foot.
- Patients on hemodialysis.
- Patients who had any pathological conditions which may affect the results of the study as active malignancy, osteomyelitis and pes planus.
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 |
|---|---|---|
| Charcot Restraint Orthotic Walker 3d printed soleThe Charcot Restraint Orthotic Walker (CROW) consists of anterior and posterior shells creating a total contact environment based on a rocker sole. the sole is manufactured by 3d printed Metamaterial . Manufacture of the 3d printed sole of the CROW paths through two stages ;Computer aided designing (CAD) and computer aided manufacturing (CAM) . | Device | Charcot Restraint Orthotic Walker 3d printed sole |
| Generic Charcot Restraint orthotic walkerIt is a clamshell (two piece) design that provides complete/total contact over the shin, calf and foot. The CROW reduces all motion in the ankle and foot to reduce potential for further injury. It is fully padded on the inside, and the bottom is covered with a material similar to shoe soling. It is not worn with a shoe. | Device | Generic Charcot Restraint orthotic walker |
Primary outcome
Force platform to measure peak vertical ground reaction plantar force
Time frame: Pre-intervention
Plantar vertical ground reaction force obtained at a rate of 100 Hz measured by Nintendo Wii Balance Board (WBB Nintendo Co. Ltd. Kyoto, Japan) through a four strain gauge sensors (uniaxial vertical force transducers) located at the corners of the board with a usable size of 45 x 26.5 cm were used for data collection; wirelessly via Bluetooth by using third party software illustrates the peak vertical force parameter.
Force platform to measure peak vertical ground reaction plantar force
Time frame: Three months post-intervention
Plantar vertical ground reaction force obtained at a rate of 100 Hz measured by Nintendo Wii Balance Board WBB (Nintendo Co. Ltd. Kyoto, Japan) through a four strain gauge sensors (uniaxial vertical force transducers) located at the corners of the board with a usable size of 45 x 26.5 cm were used for data collection; wirelessly via Bluetooth by using third party software illustrates the peak vertical force parameter
2 secondary outcomes
Wound Surface area using ImageJ software
Time frame: Pre-intervention
Wound Surface area using ImageJ software
Time frame: Three months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
Related trials for Charcot Joint of Foot
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
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.
Amal M Abd El Baky, PhD study director
faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charcot Restraint Orthotic Walker 3d printed sole and Generic Charcot Restraint orthotic walker in people with Charcot Joint of Foot, run by Cairo 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 25 Jun 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force platform to measure peak vertical ground reaction plantar force (time frame: Pre-intervention). The study lists 2 primary outcomes in all. 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 25 Jun 2021.