E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The treatment of chronic diabetic foot ulcers of longer than 12weeks duration. |
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E.1.1.1 | Medical condition in easily understood language |
Diabetic foot ulcers are a significant complication of Diabetes [Type 1 and Type 2], affecting 1:4 diabetics. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Cell Physiological Phenomena [G04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016980 |
E.1.2 | Term | Foot ulcer |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this pilot study, is to determine safety and efficacy of the addition of the RAPID PRP Gel treatment to usual and customary care, in complete wound healing of chronic diabetic foot ulcers, within 12 weeks
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are: 1. To investigate the correlation between the defined treatment modalities and wound infection. 2. To investigate the correlation between the defined treatment modalities and number of patients proceeding to amputations. 3. To investigate the correlation between the defined treatment modalities and pain scores. 4. To investigate the health-related quality of life and patient satisfaction. 5. Define the cost of treatment between the two treatment arms.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients will be eligible for this study if they meet the following inclusion criteria: 1. Ability to give written informed consent 2. Male or female with confirmed type 1 or type 2 diabetes. 3. Age 18-90 years. 4. Diabetic foot ulcer (DFU) measuring more than 0.5cm x 0.5cm and lesser than 10cm x 10cm, present for more than 12 weeks. 5. Only one ulcer present on the affected limb. 6. Patient understands and is willing to participate and can comply with the follow-up regime. 7. Patient understands and is willing to participate in full UCC, including recommended off-loading strategy
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E.4 | Principal exclusion criteria |
Patient will be consdiered inelgible if they have any of the following:
1. Wound with active infection which simple debridement cannot eradicate; any post-debridement remaining underlying osteomyelitis 2. Patients with underlying vascular insufficiency (If ABPI<0.9 or ABPI>1.3, duplex or other arterial imaging will be required to demonstrate in-line flow into the foot). 3. Uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%. (86mmol/mol) 4. Hb<10.5g/dl 5. One or more of the following medical comorbidities - hepatic, hematologic, active auto-immune or immune diseases. 6. Patient with known or suspected current malignancy. 7. Patient not fit for surgery (ASA classification > 4) 8. Poor venous access. 9. Critical thrombocytopenia 10. Septicemia 11. Platelet count of<100/ul 12. Serum albumin of <2.5g/dL 13. Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is the proportion of wounds healed at 12weeks. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Wounds will be measured and photographed from the commencement of treatment, on a weekly basis until 100% wound healing is achieved.
The cut off point of treatment using the RAPID Biodynamic PRP Haematogel is if <50% wound healing is achieved by week 6. |
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E.5.2 | Secondary end point(s) |
The Secondary endpoints include:
¬ Incidence of amputations. ¬ proportion of completely healed DFUs (University of Texas DFU Classifications). ¬ change in the Wound QoL and EQ-5D-5L Questionnaire mean scores. ¬ To investigate the correlation between the defined treatment modalities and wound microbiology and antibiotic usage
Exploratory endpoints/outcomes ¬ To investigate the correlation between the defined treatment modalities and wound complications. ¬ Investigate the overall cost effectiveness of the RAPID PRP gel wound dressing treatments in comparison to standard dressing regimes.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Interim Time points for evaluation at 12weeks. Final evaluation time point is the scheduled 6month follow up appointment.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Usual and Customary Care and Aquacel as the primary dressing. |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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RAPID-1 DFU Study will end when the last patient has had their final study visit for review of patient and wound closure (scheduled at 12 weeks post randomisation plus 6months - visit 14). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 30 |