Adults 3 to 18, any sex, with Flat Foot or Pressure Ulcer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)Primary· 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
Group
Value
95% CI
Polyurethane Foam
17
Standard Care
21
Pain (Score on the "Numeric Rating Scale")Secondary· up to the first 3 days post intervention
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.
Group
Value
95% CI
Polyurethane Foam
26
Standard Care
25
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06211504 — Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult
· Phase 4
· recruiting
Other Istituto Ortopedico Rizzoli trials
Trials by the same sponsor.
NCT07590882 — Evaluation of Return to Sports Activity After Periacetabular Osteotomy: An Observational Study
· enrolling by invitation
NCT07021222 — Multifactorial Strategies for the Prevention of the Risks of Ulceration in Patients Affected by Diabetic Foot (DARE-DiaF
· NA
· recruiting
NCT07360964 — Clear Cell Chondrosarcoma in Italy
· NA
· active not recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istituto Ortopedico Rizzoli
Last refreshed: 5 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03039179.