ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03369756
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
B. Braun Medical Inc.

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.

Condition or disease Intervention/treatment
Wound of Lower Leg (Physical Finding) Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel

Study Type : Observational
Estimated Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Prontosan Solution and Gel
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Wound cleansing using Prontosan solution and gel




Primary Outcome Measures :
  1. Wound-QoL Global Score [ Time Frame: 4 weeks ]

    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.



Secondary Outcome Measures :
  1. Wound QoL Subscore; Body dimension [ Time Frame: 4 weeks ]

    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". It can be used in clinical and observational studies and in daily practice.

    Subscale "Body" consists of Items #1 to #5. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale 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.


  2. Wound QoL Subscore; Psyche dimension [ Time Frame: 4 weeks ]

    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". It can be used in clinical and observational studies and in daily practice.

    Subscale "Psyche" consists of Items #Items #6 to #10. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale 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.


  3. Wound QoL Subscore; Everyday Life dimension [ Time Frame: 4 weeks ]

    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". It can be used in clinical and observational studies and in daily practice.

    Subscale "Everyday Life" consists of Items #Items #11 to #16. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. Generally, the higher values represents more of an impact to the patient for that item.



Other Outcome Measures:
  1. Wound Appearance [ Time Frame: 4 weeks ]
    Change from baseline in wound appearance. The change in the appearance of a wound will be evaluated using photographs. Pictures will be taken before and after wound cleansing.

  2. Wound Size [ Time Frame: 4 weeks ]
    Change from baseline in wound size. The change in the size of a wound will be evaluated using a disposable ruler to directly measure the overall wound dimensions at each scheduled visit to the study site. These measurements will be done before any cleaning of the wound and after cleaning the wound.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Current patients at primary care clinics and wound care centers.
Criteria

Inclusion Criteria:

  • 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 ≥10 cm2 and ≤16 cm2 and it also must be present for ≥12 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)

Exclusion Criteria:

  • 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 14 days prior to baseline (i.e., prior to first administration of study treatment)
  • Previous diagnosis of peripheral artery disease, an Ankle Brachial Index of ≤ 0.7, and/or patient has no palpable pulse on both dorsal pedis and posterior tibial arteries of the affected limb
  • Presence of gangrene in the wound(s) or on the leg(s)
  • Active rheumatic or collagen vascular disease (including rheumatoid arthritis, scleroderma, and systemic lupus erythematosus), psoriasis, sarcoidosis, or other skin disease. 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
  • Currently receiving or has received oral, inhaled, 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
  • Clinical laboratory values that may impair wound healing; for example, plasma total protein <4 g/dL, 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
  • 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
  • Lymphedema as diagnosed by clinical findings in inferior members (e.g., legs)
  • 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)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369756


Contacts
Contact: Diana Valencia, MD 610-596-2875 diana.valencia@bbraunusa.com
Contact: Christopher R Curtin 610-596-2726 chris.curtin@bbraunusa.com

Locations
United States, Florida
Barry University Clinical Research Recruiting
North Miami Beach, Florida, United States, 33169
Contact: Maria Swartz    305-836-7550    mswartz@barry.edu   
Principal Investigator: Robert Snyder, DPM         
United States, Pennsylvania
St. Luke's Wound Care Center Not yet recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Susan Hahn    484-526-7825    Susan.hahn2@sluhn.org   
Principal Investigator: Steven Bowers, DO         
Sponsors and Collaborators
B. Braun Medical Inc.

Additional Information:
Publications:
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

Responsible Party: B. Braun Medical Inc.
ClinicalTrials.gov Identifier: NCT03369756     History of Changes
Other Study ID Numbers: OPM-G-H-1506
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Wounds and Injuries
Pharmaceutical Solutions