Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
NCT ID:
NCT02531750
Eligibility Criteria:
Inclusion Criteria:
* Individuals of age 18 to 70 years
* Rupture of Achilles tendon happened within 5 days.
* The patient must be expected to be able to attend rehabilitation and post-examinations.
* The patient must be able to speak and understand Danish.
* The patient must be able to give informed consent.
Exclusion Criteria:
* Former rupture of one or both Achilles tendon(s)
* Previous surgery on the Achilles tendon
* Fluoroquinolone treatment within the last 6 months
* Tendinosis treated with corticosteroids (tablets or injections) within the last 6 months.
* The patient has been diagnosed with arterial insufficiency in the legs.
* Terminal illness or severe medical illness: ASA score higher than or equal to 3.
* The space between the rupture and the calcaneus is less than 1cm.
* BMI \>/= 35 kg/m2
* Known diabetes mellitus or HbA1c \>/= 48 mol/mol
* Clinical significant anaemia, liver or kidney disease as judged by the sponsor or principal investigator.
* Thyroid function abnormality (TSH \< 0.1 or TSH \> 10)
* Calcium metabolic derangement, Ca++ \< 1.1 or Ca++ \> 1.40
* Known osteoporosis
* Re-rupture of the Achilles tendon between week 8 and 52
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02531750
Study Brief:
Protocol Section:
NCT02531750