Flat FootSCHIUMABIMBNCT03039179

Polyurethane Foam on the Heel for Prevention in Children

A study testing polyurethane foam dress in people with Flat Foot and Pressure Ulcer, run by Istituto Ortopedico Rizzoli.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 3 to 18 years
Conditions the study is for: Flat Foot, Pressure Ulcer
What is being tested?: polyurethane foam dress
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: No sites listed yet
Study dates: 1 Jul 2014to 31 Aug 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Children aged > 3 years underwent surgery for flat foot
Children with intact skin at the heel

Who cannot join

Caregivers who cannot speak Italian
Those who refuse to give their consent to take part in the study
Patients with lower limb casts after surgery

About this study

Official title: Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial

The post-operative treatment of pediatric patients operated for the correction of flat foot, sees today the use of preformed leg-foot splint (Walker) as an alternative to the application of plaster casts. The change of the immobilization system has led to the appearance of problems of tolerability in particular in the skin. The aim of the study is to assess whether by placing a polyurethane foam dress at the heel in the immediate postoperative period until removal of the Walker, the rate of skin lesion and pain is reduced.

Conditions: Flat Foot, Pressure Ulcer
Being tested: polyurethane foam dress
Medical subject headings: Flatfoot, Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

polyurethane foam dressDevice
Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker

Study groups in NCT03039179
Study group	Role	What they receive
Polyurethane foam	Experimental	Not described Receives: Device: polyurethane foam dress
standard care	No intervention	Only application of the Walker in the immediate postoperative period.

What is being measured

The primary outcome is the main question the study is designed to answer.

Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)
Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.
Measured: every day until discharge (expected average of 3 days)

Secondary outcomes (1)

Pain (Score on the "Numeric Rating Scale")
Pain Score on the "Numeric Rating Scale" > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.
Measured: up to the first 3 days post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201431 Aug 2015

First posted1 Feb 2017 (estimated)
Study start1 Jul 2014
Primary completion31 Jul 2015
Study completion31 Aug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Flat FootStudies of the same condition, open and under way.
More trials run by Istituto Ortopedico RizzoliThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03039179
Sponsor's protocol ID: 0024520
Acronym: SCHIUMABIMB
Status last verified: Apr 2017
First submitted: 31 Jan 2017
Last updated: 5 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
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Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
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The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
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All Flat Foot trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03039179
Acronym / sponsor ID: SCHIUMABIMB / 0024520
Conditions: Flat Foot, Pressure Ulcer
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Istituto Ortopedico RizzoliUniversity, hospital or other
Study start: 1 Jul 2014 (actual)
Primary completion: 31 Jul 2015 (actual)
Study completion: 31 Aug 2015 (actual)
First posted: 1 Feb 2017 (estimated)
Results: Posted 22 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Polyurethane foam	Experimental	Device: polyurethane foam dress
standard care	No intervention	–Only application of the Walker in the immediate postoperative period.

Who may qualify

Ages: 3 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Children aged > 3 years underwent surgery for flat foot
Children with intact skin at the heel

Key exclusion criteria (3 listed)

Caregivers who cannot speak Italian
Those who refuse to give their consent to take part in the study
Patients with lower limb casts after surgery

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
polyurethane foam dressApplication of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker	Device	Polyurethane foam

Primary outcome

Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)
Time frame: every day until discharge (expected average of 3 days)
Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.

1 secondary outcome

Pain (Score on the "Numeric Rating Scale")
Time frame: up to the first 3 days post intervention

Results and safety

Results posted to the registry on 22 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Polyurethane Foam	38	38
Standard Care	42	42

Primary outcome: Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)

Time frame: every day until discharge (expected average of 3 days). Count of participants. Unit: Participants

Measure	Polyurethane Foam n = 38	Standard Care n = 42
Value	17	21

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Polyurethane Foam	0 of 38 (0%)	0 of 38 (0%)	0 of 38
Standard Care	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Flat Foot

Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation

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.

Caterina Guerra, RN principal investigator

Istituto Ortopedico Rizzoli

Questions about this trial

What is this clinical trial studying?

A study testing polyurethane foam dress in people with Flat Foot and Pressure Ulcer, run by Istituto Ortopedico Rizzoli.

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 3 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 22 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores) (time frame: every day until discharge (expected average of 3 days)). 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 NCT03039179.

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 5 Feb 2020.