A

Phase 1

• Conditions: Hard-to-Heal (HTH) venous leg ulcer; MedDRA version: 21.1Level: LLTClassification code 10066677Term: Chronic leg ulcerSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-000536-10-PL
• Lead Sponsor: Promore Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-21
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

1. Capable and voluntarily giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Provision of signed and dated written ICF must be prior to any mandatory study specific procedures, sampling and analyses.
2. Male or female =18 years of age at the time of signing the ICF
3. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) until the last dose of LL-37/matching placebo to prevent pregnancy. In addition, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
4. Negative pregnancy test (women of child-bearing potential only)
5. Lower leg ulcers presumed to be caused by venous insufficiency
6. Target leg ulcer that has failed to heal within a minimum of 6 weeks of compression therapy
7. Ankle-brachial pressure index (ABI) >0.70 at screening
8. Ulcer localisation above the foot and below the knee (ankle and malleoli included)
9. Surface area of target ulcer 2 to 40 cm2 at screening
10. Ulcer essentially free of necrotic tissue
11. Ability to tolerate compression bandaging
12. Appropriate state of health to participate in the study, as determined by the investigator. This will be determined by medical history, physical examination and clinical laboratory evaluations
13. Willing to attend study visits and judged able to comply with the protocol requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 79
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

1. Other known predominant aetiology than VLU of the target ulcer, such as trauma
2. Malignant disease (excluding basal cell carcinoma) unless in remission for 5 years
3. P-albumin <25 g/L or HbA1c >10%
4. Presence of active psoriasis skin lesions within 1.5 cm of the ulcer area
5. Ulcer which by location or extension is either difficult to assess or treat according to the protocol
6. Presence of a non-study ulcer within 2 cm of the target VLU
7. Exposure of bone, tendon or fascia within the target ulcer
8. Clinical signs or symptoms of an infection of the target ulcer, erysipelas, or osteomyelitis requiring systemic antibiotic treatment
9. Systemic immunosuppressive drugs with the exception of low-dose oral steroids: glucocorticoids corresponding to oral prednisolone =10 mg/day are allowed provided that drug treatment has been initiated not earlier than 4 weeks prior to the screening visit and at that time point, is expected to be maintained at similar dose level throughout the study period. Also, mineral corticoids are permitted.
10. Known hypersensitivity to any component of the study drug or standard ulcer dressing allowed during study treatment period or follow-up period
11. Systemic treatment with antibiotics within 7 days prior to screening visit
12. Participation in another clinical study within 7 days prior to screening visit
13. Treatment with any of the following medications on the target ulcer on the day of screening: topical antibiotics, potassium permanganate
14. Presence of heavy ulcer exudation that requires more frequent dressing changes than are allowed in the study (i.e. twice weekly) as judged by the investigator
15. For women only: currently pregnant (confirmed by positive pregnancy test) or breast-feeding
16. Any clinically significant disease judged by the investigator to affect the patient’s capability to participate in the study or to possibly influence the evaluation of study data

Additional criterion to be checked at randomisation visit:
17. Reduction in the target ulcer area per week during run-in period:
a. >7% for an ulcer with an initial area of >10 cm2
b. >10% for an ulcer with an initial area of =2 to =10 cm2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified