RAPID-1 Diabetic Foot Ulcer Randomised Controlled Study

Phase 1

• Conditions: The treatment of chronic diabetic foot ulcers of longer than 12weeks duration.; MedDRA version: 20.0 Level: LLT Classification code 10016980 Term: Foot ulcer System Organ Class: 100000004858; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2018-003596-36-GB
• Lead Sponsor: Biotherapy Services Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 66

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified