Clinical trial NCT03369756: Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)
Official title: A Prospective Study of Quality of Life in Patients With Chronic Leg Wound(s) Treated With Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wound of Lower Leg (Physical Finding)
Lead sponsor: B. Braun Medical Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of chronic leg wounds in adults. All participants will use Prontosan and report their personal observations regarding Quality of Life.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥18 years of age
2. Either 2 wounds on 1 leg or 1 wound on each leg or only 1 wound. Wound(s) must be located below the knee.
3. At least one wound must have a surface area ≥5 cm2 and ≤50 cm2 and it also must be present for ≥4 weeks
4. Mean global score ≥1.18 on the Wound-QoL questionnaire (this will be calculated by the electronic data capture \[EDC\] system at the time of screening to assess eligibility)
5. Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or walker)

Exclusion Criteria:

1. Prior treatment with Prontosan solution or Prontosan gel on the wound(s)
2. Infection in the wound(s)
3. Cartilage exposure in the wound(s)
4. Antibiotic therapy within 7 days prior to baseline (i.e., prior to first administration of study treatment). Topical antibiotics not applied to the wound are acceptable.
5. Current diagnosis of severe peripheral artery disease as indicated by clinical findings (i.e., no palpable pulse on both dorsal pedis and posterior tibial arteries of the affected limb) or an Ankle Brachial Index of \< 0.5
6. Presence of gangrene in the wound(s) or on the leg(s)
7. Active (flare up) rheumatic or collagen vascular disease (including rheumatoid arthritis, scleroderma, and systemic lupus erythematosus), psoriasis, sarcoidosis, or other skin disease. These subjects are allowed to receive oral, inhaled, or parenteral corticosteroids, immunosuppressive agents, or cytotoxic agents. Note: fibromyalgia is acceptable.
8. Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within 90 days prior to the screening visit
9. Active radiation therapy below the hip
10. Subjects with medical conditions other then those identified in Exclusion Criteria 7 who are currently receiving or has received oral, or parenteral corticosteroids, immunosuppressive agents, or cytotoxic agents within 30 days prior to baseline (i.e., prior to first administration of study treatment) or is anticipated to require such agents during the course of the study
11. Clinical laboratory values that may impair wound healing; for example, hemoglobin \<10 g/dL, or HbA1c ≥12%
12. Enrolled in any investigational drug or device study for any disease/indication within 30 days prior to the screening visit
13. Unable to comprehend or comply with study requirements, or inability to sign an informed consent form
14. Allergic to any of the components in Prontosan solution or Prontosan gel
15. Patients who, in the opinion of the Investigator, would not be suitable candidates for this study or have some impediment to their ability to heal
16. Preplanned surgery or procedures that would occur during the study (other than deemed minor and clinically non-significant by the Investigator) or that would interfere with the study
17. Phase 4 pressure ulcer as defined by full-thickness skin and tissue loss with exposed or directly palpable fascia, muscle, tendon, ligament, cartilage or bone in the ulcer. Slough and/or eschar may be visible
18. Severe secondary lymphedema as diagnosed by clinical findings in inferior members (e.g., legs)
19. A diagnosis of malnutrition as determined by either a low BMI (\<18.5 kg/m2), or on the combined finding of weight loss together with reduced BMI (age-specific)
20. Employee of the Investigator or study center, with direct involvement in the study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator

Primary outcomes:
measure: Wound-QoL Global Score
timeFrame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
Secondary outcomes:
measure: Wound QoL Subscore; Body Dimension
timeFrame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
measure: Wound QoL Subscore; Psyche Dimension
timeFrame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
measure: Wound QoL Subscore; Everyday Life Dimension
timeFrame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
Other outcomes:
measure: Wound Size
timeFrame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
Locations:
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: North Miami Beach
country: United States
facility: Barry University Clinical Research
state: Florida
city: N. New Hyde Park
country: United States
facility: Northwell Comprehensive Wound Care Healing Center and Hyperbarics
state: New York
city: Bethlehem
country: United States
facility: St. Luke's Wound Care Center
state: Pennsylvania
city: Harrisburg
country: United States
facility: Harrisburg Foot and Ankle Center
state: Pennsylvania
Study officials:
References:
citation: Richmond NA, Maderal AD, Vivas AC. Evidence-based management of common chronic lower extremity ulcers. Dermatol Ther. 2013 May-Jun;26(3):187-96. doi: 10.1111/dth.12051.
citation: Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
citation: McCarty SM, Percival SL. Proteases and Delayed Wound Healing. Adv Wound Care (New Rochelle). 2013 Oct;2(8):438-447. doi: 10.1089/wound.2012.0370.
citation: Leaper DJ, Schultz G, Carville K, Fletcher J, Swanson T, Drake R. Extending the TIME concept: what have we learned in the past 10 years?(*). Int Wound J. 2012 Dec;9 Suppl 2(Suppl 2):1-19. doi: 10.1111/j.1742-481X.2012.01097.x.
citation: Romanelli M, Dini V, Barbanera S, Bertone MS. Evaluation of the efficacy and tolerability of a solution containing propyl betaine and polihexanide for wound irrigation. Skin Pharmacol Physiol. 2010;23 Suppl:41-4. doi: 10.1159/000318266. Epub 2010 Sep 8.
citation: Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
citation: Blome C, Baade K, Debus ES, Price P, Augustin M. The "Wound-QoL": a short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments. Wound Repair Regen. 2014 Jul-Aug;22(4):504-14. doi: 10.1111/wrr.12193.
citation: Augustin M, Baade K, Herberger K, et al. Use of the Wound-QoL instrument in routine practice: feasibility, validity, and development of an implementation tool. Wound Medicine. 2014;5:4-8