Wound of Lower Leg (Physical Finding)NCT03369756

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

A study testing Prontosan Wound Irrigation Solution and Prontosan Wound Gel in people with Wound of Lower Leg (Physical Finding), run by B. Braun Medical Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound of Lower Leg (Physical Finding)
What is being tested?: Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 5 sitesUnited States
Study dates: 20 Feb 2018to 25 Sep 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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)

Show all 20Show fewer

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
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
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
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
Severe secondary 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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

St. Luke's Wound Care Center
Bethlehem, Pennsylvania, 18015
Harrisburg Foot and Ankle Center
Harrisburg, Pennsylvania, 17112
Jupiter Medical Center
Jupiter, Florida, 33458
Barry University Clinical Research
North Miami Beach, Florida, 33169
Northwell Comprehensive Wound Care Healing Center and Hyperbarics
North New Hyde Park, New York, 11042

Other trials in United States

About this study

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

Conditions: Wound of Lower Leg (Physical Finding)
Being tested: Prontosan Wound Irrigation Solution and Prontosan Wound Gel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prontosan Wound Irrigation Solution and Prontosan Wound GelDevice
Wound cleansing using Prontosan solution and gel

Study groups in NCT03369756
Study group	Role	What they receive
Prontosan Solution and Gel	Other	Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period Receives: Device: Prontosan Wound Irrigation Solution and Prontosan Wound Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201825 Sep 2019

First posted12 Dec 2017
Study start20 Feb 2018
Primary completion25 Sep 2019
Study completion25 Sep 2019

Why it stopped: Terminated due to prolonged subject recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Wound of Lower Leg (Physical Finding)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03369756
Sponsor's protocol ID: OPM-G-H-1506
Status last verified: Nov 2020
First submitted: 6 Dec 2017
Last updated: 8 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 23742279
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.
PubMed 26339534
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.
PubMed 24688830
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.
PubMed 23145905
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.
PubMed 20829661
Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
PubMed 25942522
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.
PubMed 24899053
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

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03369756
Acronym / sponsor ID: OPM-G-H-1506
Conditions: Wound of Lower Leg (Physical Finding)
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated due to prolonged subject recruitment
Enrolment: 43 participants (actual)
Lead sponsor: B. Braun Medical Inc.Industry (pharma, biotech, devices)
Study start: 20 Feb 2018 (actual)
Primary completion: 25 Sep 2019 (actual)
Study completion: 25 Sep 2019 (actual)
First posted: 12 Dec 2017 (actual)
Results: Posted 8 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Prontosan Solution and Gel	Other	Device: Prontosan Wound Irrigation Solution and Prontosan Wound GelTreatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prontosan Wound Irrigation Solution and Prontosan Wound GelWound cleansing using Prontosan solution and gel	Device	Prontosan Solution and Gel

Primary outcome

Wound-QoL Global Score
Time frame: 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.

3 secondary outcomes

Wound QoL Subscore; Body Dimension
Time frame: 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
Time frame: 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
Time frame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)

Results and safety

Results posted to the registry on 8 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prontosan Solution and Gel	43	36

Primary outcome: Wound-QoL Global Score

Time frame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5). Mean (Standard Deviation). Unit: score on a scale

Measure	Prontosan Solution and Gel n = 36
Week 1 / Baseline	2.41 (0.99)
Week 2	1.74 (1.15)
Week 3	1.51 (0.95)
Week 4	1.25 (0.90)
Week 5 / End	1.30 (0.87)

Population analysed: All subjects who completed 4 weeks of treatment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening through 4th week of treatment (5 weeks total).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prontosan Solution and Gel	5 of 43 (11.6%)	14 of 43 (32.6%)	0 of 43

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23742279Richmond 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.
Background: PubMed 26339534Frykberg 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.
Background: PubMed 24688830McCarty 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.
Background: PubMed 23145905Leaper 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.
Background: PubMed 20829661Romanelli 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.
Background: PubMed 25942522Andriessen AE, Eberlein T. Assessment of a wound cleansing solution in the treatment of problem wounds. Wounds. 2008 Jun;20(6):171-5.
Background: PubMed 24899053Blome 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.
BackgroundAugustin 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
Wound-QoL Short Manual, dated September 2015Link provided by the sponsor.
Measuring wounds on Wound Care AdvisorLink provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prontosan Wound Irrigation Solution and Prontosan Wound Gel in people with Wound of Lower Leg (Physical Finding), run by B. Braun Medical Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound-QoL Global Score (time frame: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03369756, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.