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:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT02360358
Eligibility Criteria:
Inclusion criteria:
* Have a (arterio) venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), or on foot (not plantar side of the foot) with a surface area ≥ 1.0 cm2 and ≤ 40.0 cm2
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed (ABPI ≥ 0.6 and ≤ 1.3)
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone. Ulcer depth \< 1 cm
* Target ulcer duration ≥ 12 weeks but ≤ 15 years
* Acceptable state of health and nutrition
* Mobile, at least able to walk with medical walker, and able to return for required treatments and study evaluations
Exclusion Criteria:
* History of anaphylaxis, serum sickness, or erythema multiforme reaction to bovine serum proteins, gentamycin.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
* \>30% change of wound size in 4 weeks or confirmed by historical data
* Presence of deep vein thrombosis or contra indication for compression therapy
* Severe co-morbidity reducing life expectance to \< 1 year
* Use of oral corticosteroids and/or cytostatics \>20 mg/per day;
* Severe infection of ulcer, active cellulitis, osteomyelitis
* Severe malnutrition
* Uncontrolled diabetes mellitus, HbA1c \> 12% (108 mmol/mol)
* Anaemia Hb \<6 mmol/l
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02360358
Study Brief:
Protocol Section:
NCT02360358