Best Tissue Constituent for Plantar SurfaceNCT03152812
Functional Outcome of Free Muscle Flaps Versus Free Skin Flaps for Post-traumatic Foot Plantar Surface Reconstruction
An observational study of Best Tissue Constituent for Plantar Surface, run by alhussein Ahmed Mahmoud El-Dahshan at 1 site in Egypt.
Trial summary
the investigators are trying to detect what is the best tissue constituent suitable for reconstruction of large post traumatic sof tissue defects of foot plantar surface Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Best Tissue Constituent for Plantar Surface
- What is being tested?
- plantar surface reconstruction by free flaps
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2017to Mar 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: any individual having post traumatic soft tissue defect of plantar surface requiring free flap reconstruction regardless to age
Who may be able to join
- Posttraumatic large soft tissue defects of plantar surface requiring free tissue transfer for coverage
- At any age
Who cannot join
- 1-defects that can be managed by local flaps 2-Non traumatic soft tissue defects
- -
Trial locations and contacts
1 site in 1 country.
About this study
the investigators are trying to detect what is the best tissue constituent suitable for reconstruction of large post traumatic sof tissue defects of foot plantar surface
- Being tested
- plantar surface reconstruction by free flaps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantar surface reconstruction by free flapsProcedure or surgery
use of free skin or free muscle flaps for reconstruction of plantar surface
| Study group | Role | What they receive |
|---|---|---|
| free skin flaps | Not described Receives: Procedure: plantar surface reconstruction by free flaps | |
| free muscle flaps | Not described Receives: Procedure: plantar surface reconstruction by free flaps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to mobilize
Measured: 2 years
Requirement of specialized Footwear
Measured: 2 years
Secondary outcomes (2)
flap ulceration
Measured: 2 years
Shear forces across the flap
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Mar 2017
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Best Tissue Constituent for Plantar SurfaceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- alhussein Ahmed Mahmoud El-Dahshan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, alhussein Ahmed Mahmoud El-Dahshan, Assiut University
- Investigators
- Amr El-Said Ali Ibrahim, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152812
- Sponsor's protocol ID
- salmaalhussein
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome of Free Muscle Flaps Versus Free Skin Flaps for Post-traumatic Foot Plantar Surface Reconstruction
- ClinicalTrials.gov ID
- NCT03152812
- Acronym / sponsor ID
- salmaalhussein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- alhussein Ahmed Mahmoud El-DahshanUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 15 May 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.
the investigators are trying to detect what is the best tissue constituent suitable for reconstruction of large post traumatic sof tissue defects of foot plantar surface
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| free skin flaps | – | Procedure: plantar surface reconstruction by free flaps |
| free muscle flaps | – | Procedure: plantar surface reconstruction by free flaps |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- any individual having post traumatic soft tissue defect of plantar surface requiring free flap reconstruction regardless to age
Key inclusion criteria (2 listed)
- Posttraumatic large soft tissue defects of plantar surface requiring free tissue transfer for coverage
- At any age
Key exclusion criteria (2 listed)
- 1-defects that can be managed by local flaps 2-Non traumatic soft tissue defects
- -
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 |
|---|---|---|
| plantar surface reconstruction by free flapsuse of free skin or free muscle flaps for reconstruction of plantar surface | Procedure or surgery | free muscle flaps, free skin flaps |
Primary outcome
Time to mobilize
Time frame: 2 years
Requirement of specialized Footwear
Time frame: 2 years
2 secondary outcomes
flap ulceration
Time frame: 2 years
Shear forces across the flap
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
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.
Amr El-Said Ali Ibrahim, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Best Tissue Constituent for Plantar Surface, run by alhussein Ahmed Mahmoud El-Dahshan 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 2 inclusion and 2 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 23 May 2017. 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?
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?
Time to mobilize (time frame: 2 years). 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 23 May 2017.