Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Photopharmica
ClinicalTrials.gov Identifier:
NCT00825760
First received: January 19, 2009
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Chronic Leg Ulcers
Wound Healing
Drug: Topical PPA904 gel and light
Drug: Topical placebo gel plus light
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers.

Resource links provided by NLM:


Further study details as provided by Photopharmica:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: Yes ]
  • 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). ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Single treatment
Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light
2
12 treatments, once weekly
Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825760

Locations
United Kingdom
Department of Vascular Surgery, Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Department of Wound Healing, Cardiff University
Cardiff, United Kingdom, CF14 4XN
Dermatology Department, Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Dermatology Department, Harrogate District Hospital
Harrogate, United Kingdom, HG2 7SX
Sponsors and Collaborators
Photopharmica
Investigators
Principal Investigator: Keith Harding, MBChB FRCS Cardiff University
  More Information

Additional Information:
No publications provided

Responsible Party: Photopharmica
ClinicalTrials.gov Identifier: NCT00825760     History of Changes
Other Study ID Numbers: PPA/904W/003
Study First Received: January 19, 2009
Last Updated: January 23, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by Photopharmica:
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

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Skin Ulcer
Pathologic Processes
Skin Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014