Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)

NCT03369756 | Terminated Results FDA Device

• 1 other identifier: OPM-G-H-1506
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 5

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.

Conditions

Wound of Lower Leg (Physical Finding)

Outcome Measures

Primary Outcomes (1)

• Wound-QoL Global Score

  The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". These subscales cover items 1 to 16. Item 17 is not part of any of the subscales. The Wound-QoL can be used in clinical and observational studies and in daily practice. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). A "Total" or "Global" score is the average of at least 13 completed questions, regardless of which questions were not completed. The average of each of the 3 subscales can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.

  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 (3)

• Wound QoL Subscore; Body Dimension

  5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

• Wound QoL Subscore; Psyche Dimension

  5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

• Wound QoL Subscore; Everyday Life Dimension

  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 (1)

• Wound Size

  5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Study Arms (1)

Prontosan Solution and Gel

OTHER

Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period

Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel

Interventions

Prontosan Wound Irrigation Solution and Prontosan Wound Gel DEVICE

Wound cleansing using Prontosan solution and gel

Prontosan Solution and Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age
• Either 2 wounds on 1 leg or 1 wound on each leg or only 1 wound. Wound(s) must be located below the knee.
• At least one wound must have a surface area ≥5 cm2 and ≤50 cm2 and it also must be present for ≥4 weeks
• 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)
• Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or walker)

You may not qualify if:

• Prior treatment with Prontosan solution or Prontosan gel on the wound(s)
• Infection in the wound(s)
• Cartilage exposure in the wound(s)
• 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.
• 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
• Presence of gangrene in the wound(s) or on the leg(s)
• 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.
• Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within 90 days prior to the screening visit
• Active radiation therapy below the hip
• Clinical laboratory values that may impair wound healing; for example, hemoglobin \<10 g/dL, or HbA1c ≥12%
• Enrolled in any investigational drug or device study for any disease/indication within 30 days prior to the screening visit
• Unable to comprehend or comply with study requirements, or inability to sign an informed consent form
• Allergic to any of the components in Prontosan solution or Prontosan gel
• 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
• 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

Sponsors & Collaborators

• B. Braun Medical Inc.: lead

Study Sites (5)

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33169, United States

Location

Northwell Comprehensive Wound Care Healing Center and Hyperbarics

North New Hyde Park, New York, 11042, United States

Location

St. Luke's Wound Care Center

Bethlehem, Pennsylvania, 18015, United States

Location

Harrisburg Foot and Ankle Center

Harrisburg, Pennsylvania, 17112, United States

Location

Related Publications (8)

• 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.

  PMID: 23742279 BACKGROUND

• 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.

  PMID: 26339534 BACKGROUND

• 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.

  PMID: 24688830 BACKGROUND

• 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.

  PMID: 23145905 BACKGROUND

• 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.

  PMID: 20829661 BACKGROUND

• Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.

  PMID: 25942522 BACKGROUND

• 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.

  PMID: 24899053 BACKGROUND

• 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

  BACKGROUND

Related Links

• Wound-QoL Short Manual, dated September 2015
• Measuring wounds on Wound Care Advisor

Limitations and Caveats

All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).

Results Point of Contact

• Title: Dr. Diana Valencia
• Organization: B. Braun Medical Inc.

diana.valencia@bbraunusa.com

610-596-2875

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 12, 2017
• Study Start: February 20, 2018
• Primary Completion: September 25, 2019
• Study Completion: September 25, 2019
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)