Chronic Leg UlcersPhase 2NCT00825760
Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
A Phase 2 study testing Topical PPA904 gel and light in people with Chronic Leg Ulcers and Wound Healing, run by Photopharmica at 4 sites in United Kingdom.
Trial summary
Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Leg Ulcers, Wound Healing
- What is being tested?
- Topical PPA904 gel and light
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Jan 2009to Sep 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Subjects will be males or females of non-childbearing status over 18 years of age.
- Subjects will have a chronic leg ulcer with an ABPI ≥ 0.6 (measured at screening).
- Subjects will have an ulcer that has been present for at least 3 months and not more than 3 years.
- Subjects will have an ulcer with an area of 2 - 100cm2 and a maximum linear dimension of 10cm.
- Subjects will have an ulcer with a total bacterial load of ≥ 104 CFU / cm2, determined within 2 weeks before the first treatment.
- Subjects will have voluntarily signed and dated a subject Informed Consent Form (ICF).
- Subjects will be, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and be willing to return to the clinic for all the required follow-up visits.
- Subjects should be of appropriate health to participate in the study, as determined by the Investigator. This will be determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
Who cannot join
- Subjects under the age of 18 years of age.
- Subjects who have taken topical or systemic antibiotics during the 2 weeks prior to screening.
- Subjects who have used any anti-microbial dressing or topical antiseptic / antimicrobial or received maggot therapy during the 2 weeks prior to screening.
- Subjects who have evidence of connective tissue disorders e.g. vasculitis or rheumatoid arthritis under active treatment.
- Subjects who have any clinically significant medical condition that would impair wound healing as determined by the investigator, including uncontrolled diabetes as determined by HbA1C (>12%) or immune disease.
- Subjects who are known to abuse alcohol or drugs currently, or to have psychological disorders that could affect follow-up care or treatment outcomes.
Show all 15Show fewer
- Subjects who have received short course corticosteroids within 30 days prior to treatment.
- Subjects who have participated in a clinical trial of any investigational drug within 4 months prior to treatment.
- Subjects who have participated in a clinical trial of any investigational device, for example dressings, within 1 month prior to treatment.
- Subjects who have previously been treated with IMP in this trial.
- Subjects who have or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment.
- Subjects with evidence of exposed bone, tendon or facia visible around the target wound.
- Subjects with photosensitivity disorders.
- Subjects with systemic infection, whether or not related to their ulcer.
- Subjects with clinically relevant (assessed by PI) active wound infection undergoing treatment.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Department of Vascular Surgery, Bradford Royal Infirmary
Bradford, BD9 6RJ
Department of Wound Healing, Cardiff University
Cardiff, CF14 4XN
Dermatology Department, Ninewells Hospital and Medical School
Dundee, DD1 9SY
Dermatology Department, Harrogate District Hospital
Harrogate, HG2 7SX
About this study
Official title: Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers.
Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing. Because we need to be careful about when we use antibiotics, this study will look at another way of killing bacteria in the ulcer. This new method involves putting a special gel on the ulcer and then shining a particular type of light (visible red light) onto the ulcer for a short period of time.
In the first part of the study, a single treatment with the gel and light will be investigated. The second part of the study will compare whether or not using the treatment once a week for 12 weeks is better than placebo.
Read more
Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9 in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral.
The research is funded by Photopharmica Ltd.
- Conditions
- Chronic Leg Ulcers, Wound Healing
- Being tested
- Topical PPA904 gel and light, Topical placebo gel plus light
- Keywords
- Antimicrobial Photodynamic Therapy, Photodynamic Therapy, PDT, Red light, Visible light, Antimicrobial, Antibacterial, Wound healing, Wound management, Leg ulcer, Chronic venous leg ulcer, Chronic wound, Wound therapy, Antimicrobial therapy
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical PPA904 gel and lightDrug
Topical placebo gel plus lightDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Single treatment Receives: Drug: Topical PPA904 gel and light; Drug: Topical placebo gel plus light |
| 2 | Other | 12 treatments, once weekly Receives: Drug: Topical PPA904 gel and light; Drug: Topical placebo gel plus light |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if repeat dose antimicrobial photodynamic therapy with PPA904 and PPA Lux 680 can cause a reduction in the bacterial content of chronic leg ulcers.
Measured: Measurement of total bacterial load of the ulcer immediately before and after each treatment.
Secondary outcomes (6)
Measurement of the levels of specific bacteria, including anaerobes, S.aureus (MSSA and MRSA), P.aeruginosa and beta-haemolytic Streptococci in the ulcer.
Measured: Immediately before and after each treatment.
Measurement of the ulcer area.
Measured: Weekly for 12 weeks post the first dose compared to pre the first dose for subjects receiving 12 doses (part 2 of the study).
Assessment of pain.
Measured: Pre the first dose and weekly for 12 weeks post the first dose for subjects receiving 12 doses (part 2 of the study).
Assessment of quality of life using the Cardiff Wound Impact Schedule
Measured: Pre the first dose and 12 weeks post the first dose for subjects receiving 12 doses (part 2 of the study).
Measurement of PPA904 levels in peripheral blood samples.
Measured: Pre-dose and 1h, 3h and 24h post-dose for subjects receiving 1 dose (part 1 of the study).
Safety parameters including: vital signs, 12 lead ECG, blood and urine samples, physical examination and adverse event questioning.
Measured: 24 hours for subjects receiving 1 dose (part 1 of the study). 6 and 12 weeks post first dose for subjects receiving 12 doses (part 2 of the study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Leg UlcersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photopharmica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Harding, MBChB FRCS, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825760
- Sponsor's protocol ID
- PPA/904W/003
- Status last verified
- Jan 2013
- First submitted
- 19 Jan 2009
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers.
- ClinicalTrials.gov ID
- NCT00825760
- Acronym / sponsor ID
- PPA/904W/003
- Conditions
- Chronic Leg Ulcers, Wound Healing
- Keywords
- Antimicrobial Photodynamic Therapy, Photodynamic Therapy, PDT, Red light, Visible light, Antimicrobial, Antibacterial, Wound healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- PhotopharmicaIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing. Because we need to be careful about when we use antibiotics, this study will look at another way of killing bacteria in the ulcer. This new method involves putting a special gel on the ulcer and then shining a particular type of light (visible red light) onto the ulcer for a short period of time.
In the first part of the study, a single treatment with the gel and light will be investigated. The second part of the study will compare whether or not using the treatment once a week for 12 weeks is better than placebo.
Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9 in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral.
The research is funded by Photopharmica Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Topical PPA904 gel and light, Drug: Topical placebo gel plus lightSingle treatment |
| 2 | Other | Drug: Topical PPA904 gel and light, Drug: Topical placebo gel plus light12 treatments, once weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will be males or females of non-childbearing status over 18 years of age.
- Subjects will have a chronic leg ulcer with an ABPI ≥ 0.6 (measured at screening).
- Subjects will have an ulcer that has been present for at least 3 months and not more than 3 years.
- Subjects will have an ulcer with an area of 2 - 100cm2 and a maximum linear dimension of 10cm.
- Subjects will have an ulcer with a total bacterial load of ≥ 104 CFU / cm2, determined within 2 weeks before the first treatment.
Key exclusion criteria (15 listed)
- Subjects under the age of 18 years of age.
- Subjects who have taken topical or systemic antibiotics during the 2 weeks prior to screening.
- Subjects who have used any anti-microbial dressing or topical antiseptic / antimicrobial or received maggot therapy during the 2 weeks prior to screening.
- Subjects who have evidence of connective tissue disorders e.g. vasculitis or rheumatoid arthritis under active treatment.
- Subjects who have any clinically significant medical condition that would impair wound healing as determined by the investigator, including uncontrolled diabetes as determined by HbA1C (>12%) or immune disease.
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 |
|---|---|---|
| Topical PPA904 gel and light | Drug | 1, 2 |
| Topical placebo gel plus light | Drug | 1, 2 |
Primary outcome
To determine if repeat dose antimicrobial photodynamic therapy with PPA904 and PPA Lux 680 can cause a reduction in the bacterial content of chronic leg ulcers.
Time frame: Measurement of total bacterial load of the ulcer immediately before and after each treatment.
6 secondary outcomes
Measurement of the levels of specific bacteria, including anaerobes, S.aureus (MSSA and MRSA), P.aeruginosa and beta-haemolytic Streptococci in the ulcer.
Time frame: Immediately before and after each treatment.
Measurement of the ulcer area.
Time frame: Weekly for 12 weeks post the first dose compared to pre the first dose for subjects receiving 12 doses (part 2 of the study).
Assessment of pain.
Time frame: Pre the first dose and weekly for 12 weeks post the first dose for subjects receiving 12 doses (part 2 of the study).
Assessment of quality of life using the Cardiff Wound Impact Schedule
Time frame: Pre the first dose and 12 weeks post the first dose for subjects receiving 12 doses (part 2 of the study).
Measurement of PPA904 levels in peripheral blood samples.
Time frame: Pre-dose and 1h, 3h and 24h post-dose for subjects receiving 1 dose (part 1 of the study).
Safety parameters including: vital signs, 12 lead ECG, blood and urine samples, physical examination and adverse event questioning.
Time frame: 24 hours for subjects receiving 1 dose (part 1 of the study). 6 and 12 weeks post first dose for subjects receiving 12 doses (part 2 of the study).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
- The 'Wound Healing Research Unit, Cardiff University' is a collaborator for this study,Link provided by the sponsor.
Related trials for Chronic Leg Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
RecruitingPhase 4
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Leg Ulcer
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
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.
Keith Harding, MBChB FRCS principal investigator
Cardiff University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical PPA904 gel and light in people with Chronic Leg Ulcers and Wound Healing, run by Photopharmica at 4 sites in United Kingdom.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine if repeat dose antimicrobial photodynamic therapy with PPA904 and PPA Lux 680 can cause a reduction in the bacterial content of chronic leg ulcers. (time frame: Measurement of total bacterial load of the ulcer immediately before and after each treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2013.