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

A Prospective Study of Quality of Life in Patients With Chronic Leg Wound(s) Treated With Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03369756

Enrollment

Registered

2017-12-12

Start date

2018-02-20

Completion date

2019-09-25

Last updated

2020-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound of Lower Leg (Physical Finding)

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.

Interventions

DEVICEProntosan Wound Irrigation Solution and Prontosan Wound Gel

Wound cleansing using Prontosan solution and gel

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Wound-QoL Global Score	5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)	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

Measure	Time frame	Description
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)	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.
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)	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.
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)	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

Measure	Time frame	Description
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)	Change in wound size from Baseline/Week 1 to Final/Week 5. 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 (Weeks 1 and 5). These measurements will be done before any cleaning of the wound and after cleaning the wound (debridement).

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	36
Total	36

Baseline characteristics

Characteristic	Prontosan Solution and Gel
Age, Continuous	63.2 years STANDARD_DEVIATION 15.34
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	15 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants
Race (NIH/OMB) White	17 Participants
Region of Enrollment United States	36 participants
Sex: Female, Male Female	19 Participants
Sex: Female, Male Male	17 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 43
other Total, other adverse events	14 / 43
serious Total, serious adverse events	5 / 43

Outcome results

Primary

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.