Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)
NCT ID: NCT03369756
Last Updated: 2020-12-08
Study Results
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View full resultsBasic Information
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TERMINATED
NA
43 participants
INTERVENTIONAL
2018-02-20
2019-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prontosan Solution and Gel
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Wound cleansing using Prontosan solution and gel
Interventions
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Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Wound cleansing using Prontosan solution and gel
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
ALL
No
Sponsors
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B. Braun Medical Inc.
INDUSTRY
Responsible Party
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Locations
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Jupiter Medical Center
Jupiter, Florida, United States
Barry University Clinical Research
North Miami Beach, Florida, United States
Northwell Comprehensive Wound Care Healing Center and Hyperbarics
North New Hyde Park, New York, United States
St. Luke's Wound Care Center
Bethlehem, Pennsylvania, United States
Harrisburg Foot and Ankle Center
Harrisburg, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
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.
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
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Document Type: Statistical Analysis Plan
Related Links
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Wound-QoL Short Manual, dated September 2015
Measuring wounds on Wound Care Advisor
Other Identifiers
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OPM-G-H-1506
Identifier Type: -
Identifier Source: org_study_id