A phase I/IIa, prospective, mono-center, randomized, open labeled, controlled study to assess the safety and efficacy of applying Iloprost locally in the fracture site to promote bone healing in patients with proximal humeral fracture - ILOBONE

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512468-71-00

Acronym

Ilobone (SIFU17)

Enrollment

Registered

2024-11-04

Start date

2022-09-21

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal humeral fracture

Brief summary

Identification of any noxious response or toxicity that has a causal relationship to the treatment. Toxicity shall be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Detailed description

Rate of humeral head necrosis, Humeral head shaft angle, Pain assessment (VAS), Quality of life (EQ-5D), Constant-Murley Score (CMS), Disabilities of the Arm, Shoulder and Hand score (DASH)

Interventions

DRUGIlomedin® 20 μg/1 ml

DRUGKonzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Identification of any noxious response or toxicity that has a causal relationship to the treatment. Toxicity shall be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).	—

Secondary

Measure	Time frame
Rate of humeral head necrosis, Humeral head shaft angle, Pain assessment (VAS), Quality of life (EQ-5D), Constant-Murley Score (CMS), Disabilities of the Arm, Shoulder and Hand score (DASH)	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026