Research & Development

We play a pivotal role in developing, supporting, creating and advancing wound therapies, diagnostics, and devices through protocol development and advice on study design and achievability.

Similarly, working closely with ‘frontline’ staff our patients and stakeholders, we act as ‘clinical connector’ or market shaper, engaging with public and private concerns to find new solutions to clinical challenges.

We have experience of all aspects of wound-related clinical studies and evaluations, including,

• Clinical study protocol development, we have considerable expertise in developing study protocols that are innovative, efficient, and achievable in terms of outcome measures, patient numbers and study timetable and milestones.
• Expertise in CTIMP (drug) and non-CTIPM (device) clinical studies.
• Gaining NHS R&D and Research Ethics approvals.
• Study costing (using the National Institute for Health Research (NIHR) study costing templates).
• Experience of working across multiple care settings (including acute/community and care homes).
• Tissue sampling (wound fluid and biopsies).
• Wound registry development, data collection and analysis.
• Quality of life and other patient reported outcome data collection.
• Development and moderating of patient and health professional focus groups.
• Data management and analysis. Creation of final reports.
• Systematic literature reviewing. Preparation of manuscripts and presentations

Research and Product Development

Taking a holistic view of the wound care innovation and translation journey to identify areas where support is justified and can make a difference. This involves developing a standardised process for service and product evaluations, clinical trials, and engagement activities.

Sustainable patient recruitment is key and locally we have broadened R&D activities and recruitment opportunities which has added activity advantages for participating NHS organisations and more importantly it benefits patients in terms of access to leading technologies and treatments.  Our portfolio includes Healthy Volunteer studies (pressure mapping and skin blood flow)  to assess the effect of compression therapies and beds, cushions, and mattresses.


     

Clinical Trials / Product Evaluation

We undertake a range of trials and projects in conjunction with commercial providers and academic institutions on a bespoke basis, tailored to specific requirements from protocol development through to reporting and publication.  We are experienced in undertaking multiple stages of clinical trials investigating both medical devices and pharmaceuticals related to wound healing, from First-in-Human trials, large-scale RCT’s to Post-Market Surveillance studies.

Also, we have close links with a health economist, enabling us to undertake cost effectiveness studies and health economics evaluations.

Patients who participate in our clinical trials and evaluations all benefit from input from a team of specialist nurses for the duration of their involvement, as well as the opportunity to be actively involved in research and engaged in their care and contributing to the body of knowledge around advancing treatments for patients living with wounds.

Some examples of the types of trials we are currently or were recently involved in include:

Huntleigh Healthcare Ltd. - Intermittent Pneumatic Compression Of the Thigh for the Treatment of lower limb wounds: a randomised control trial.

The IPCOTT Study – This study is investigating the potential of a new treatment device to increase the healing rates for patients with hard-to heal leg ulcers when compared to standard treatment.


 

Medical Ethics Ltd. - An open, randomised, parallel group controlled single centre safety study to assess the safety and efficacy of Tri-Solfen in providing anaesthesia prior to surgical debridement of leg ulcers and post-operative pain relief (First-in-Human Study) – This study is investigating a novel product designed to reduce pain for patients pre- and post-debridement of their leg ulcers, a procedure required for wound bed management and promotion of wound healing, but which can cause pain and be difficult to tolerate for patients.

 

FirstKind Ltd. - Microcirculatory Flux and Pulsatility in Arterial Leg Ulcers is Increased by Intermittent Neuromuscular Electrostimulation of the Common Peroneal Nerve (Non-Comparative Study) - This study found that neuromuscular electrical stimulation increased microcirculatory blood flow to the wound bed and edge in patients with ischemic lower limb wounds.

This treatment may have the potential to promote wound healing, including in patients unsuitable for other forms of treatment or  surgery for arterial leg ulcers.



 

Clinical Research Monitoring

We developed from and built on the legacy of a long-standing history and involvement within wound healing research. Our record of conducting clinical research to internationally recognised standards in many formats supports our Clinical Research Organisation service as part of our offering. We are also highly experienced with the regulatory aspect of conducting clinical trials and offer project management from study conception to completion and we of course adhere to all applicable regulations and guidelines to include ICH, GCP, and ISO 14155.  This ensures the scientific conduct of the clinical investigation and the credibility of the clinical investigation results while protecting the rights, safety, and well-being of all clinical trial participants.

WWIC can offer the following as part of its CRO and project management activities:

• Clinical protocol development
• Site & Investigator Identification
• Clinical Trial Set-up, including regulatory, REC and R&D applications
• Site Initiation & Training
• Trial monitoring throughout its duration, including visiting the trial sites when indicated, to perform source data verification, review recruitment, protocol compliance and product accountability, ensure essential documents are filed and that the study is being conducted according to recognised standards and regulatory requirements
• Trial completion and site closure
• Preparation of final reports and manuscripts for publication as required