Assessing the Efficacy of Anti-staphylococcal Phages in the Management of Infected Foot Ulcers in Diabetes

NCT04289948 | Withdrawn Phase 1 DMC

• 1 other identifier: DHRD/2018/080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Work Package 1: Observational cohort pilot safety study Work Package 2: Randomised, double-blind, placebo controlled pilot study Work Package 3: Observer-blind pilot RCT

Conditions

Diabetes; Diabetic Foot; Diabetic Foot Infection

Keywords

Diabetes; Diabetic Foot Disease; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (3)

• Work Package 1: To assess the safety of the use of anti-staphylococcal phages therapy on the wound bacterial microbiome of uninfected DFU's.

  \- Safety : Clinically significant change in safety bloods, vital signs, Full Blood Count (FBC), renal function, C-Reactive protein (CRP), Liver function Tests (LFT)s, Adverse events

  7 months

• Work Package 2

  To compare the effect on the microbiome of empirical systemic antibiotic therapy alone (ESAT) versus ESAT plus phage therapy in ulcers complicated by mild or moderate infection as assessed by IDSA criteria

  16 months

• Work Package 3

  To compare the use of empirical systemic antibiotic therapy versus phage therapy in ulcers complicated by mild infection on the eradication of the infection as assessed by IDSA criteria.

  16 months

Secondary Outcomes (8)

• Work Package 1: Safety of phage gel and overt toxic effect of phage gel.

  7 months

• Work Package 1: • Impact on the bacterial microbiome of anti-staphylococcal phage gel and systemically chosen antibiotics.

  7 months

• Work Package 2: Safety of phage gel and overt toxic effect of phage gel.

  7 months

• Work Package 2: Clinical benefit and patient well-being associated with adding phage gel to systemically chosen antibiotics compared to placebo in the management of mild or moderate infection.

  16 months

• Work Package 2: Impact on the bacterial microbiome of systemically chosen antibiotics and of anti-staphylococcal phage gel.

  16 months

Study Arms (2)

Phage

EXPERIMENTAL

Drug: Phage

Placebo

PLACEBO COMPARATOR

Drug: Phage

Interventions

Phage DRUG

The studies will be undertaken using a cocktail of at least 2-3 anti-staphylococcal phages produced by Intralytix Inc, Baltimore, Maryland, USA. The phages will be included in a gel designed for application directly to the wound surface and packaged in 5 ml single use tubes.

Phage; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes Mellitus according to WHO criteria
• are aged 18 years or over
• Additionally, patients must meet one of the following criteria to participate in the described Work Package:
• Patients are only eligible for WP1 if they also have one or more DFUs (area 25mm2) below the malleoli without infection according to IDSA criteria that have been present for at least 4 weeks
• Patients are only eligible for WP2 if they also have one or more DFUs (area 25mm2) below the malleoli with mild or moderate infection according to IDSA criteria that have been present for at least 4 weeks
• Patients are only eligible for WP3 if they also have one or more DFUs (area 25mm2) below the malleoli with mild infection according to IDSA criteria that have been present for at least 4 weeks

You may not qualify if:

• We will exclude patients who meet ANY of the following criteria:
• with mental incapacity to give informed consent,
• who have other major co-morbidities, which in the opinion of the investigator would mean that the patient would not be able to complete the study
• with significant peripheral arterial disease (PAD): ABPI (ankle brachial pressure index) \<0.7,
• Who have osteomyelitis defined by agreed clinical criteria
• who are receiving treatment with systemic glucocorticoids or other immunosuppressants,
• who have received systemic or topical antibiotics in the preceding 14 days,
• who are judged to require parenteral administration of antibiotics,
• Who have been previously recruited to an earlier part of the project
• who are women of childbearing age who are at risk of conception
• History of antibiotic hypersensitivity

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• Wellcome Trust: collaborator
• BioPhage Theraputics Limited: collaborator
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

University Hospitals Derby and Burton NHS Foundation Trust

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Work Package 1: Observational cohort pilot safety study Work Package 2: Randomised, double-blind, placebo controlled pilot study Work Package 3: Observer-blind pilot RCT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: February 28, 2020
• Study Start: March 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

GB (1)