Diabetic foot ulcers Skin and Connective Tissue Diseases
Conditions
Interventions
Current intervention as of 25/01/2021:
The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomised trial in which DFUs
Sponsors
Biotherapy Services Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 25/01/2021: 1. Ability to give informed consent 2. Male or female with confirmed type 1 or type 2 diabetes 3. Aged 18-90 years 4. Diabetic foot ulcer (DFU) measuring more than 0.5 x 0.5 cm and less than 10 x 10 cm, present for more than 12 weeks 5. Only one ulcer present on the affected foot 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 Usual and Customary Care (UCC) including recommended off-loading strategy _____ Previous inclusion criteria: 1. =18 years of age 2. Type I or II diabetes requiring medical treatment as determined by the physician 3. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) is a University of Texas DFU Classification that is located on the dorsal, plantar, medial, or lateral aspect of the foot or heel (including all toe surfaces) 4. For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected as the Index Ulcer for study. There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure) 5. Debrided ulcer size between 0.5 cm2 and 50 cm2 6. Subject has received UCC care for = 2 weeks at treating wound clinic 7. Demonstrated adequate offloading regimen 8. Duration of wound = 1 month at first visit 9. Subject must be willing to comply with the Protocol, which will be assessed by the enrolling clinician 10. The wounds require intervention by a surgeon or specialist clinician 11. Patients must have adequate vasculature, i.e. palpable pedal pulses or in line flow-to-foot on angiogram
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/01/2021: 1. Wound with active infection which simple debridement cannot eradicate including exposed osteomyelitis; however, osteomyelitis of deep unexposed bone treated with antibiotics can be included 2. Patients with underlying vascular insufficiency. (If pedal pulse is absent and ABPI1.3, 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% (86 mmol/mol) 4. Hb 4) 8. Poor venous access 9. Critical thrombocytopenia 10. Septicaemia 11. Platelet count of <100 x 10(9)/l 12. Serum albumin of <2.5 g/dl 13. Pregnancy _____ Previous exclusion criteria: 1. Patients who refuse consent to participate in the study 2. Presence of another wound that is concurrently treated and might interfere with treatment of the index wound by the RAPID© biodynamic haematogel 3. Ulcers not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology) 4. Patients on chemotherapeutic agents or any malignancy in the wound area 5. Subjects who are cognitively impaired 6. Serum albumin of less than 2.5 g/dL 7. Plasma platelet count of less than 100 x 10(9)/L 8. Haemoglobin of less than 10.5 g/dL 9. Subject has inadequate venous access for repeated blood draw required for the RAPID biodynamic haematogel administration 10. Abnormal blood clotting dyscrasia, e.g. haemophilia 11. Evidence of bacteraemia, septicaemia or endocarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of healed DFUs at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of amputations 2. Proportion of completely healed DFUs 3. Change in the W-QOL (Quality of Life with Chronic Wounds short-form instrument) mean score 4. Visual analogue scale pain score 5. Wound infection 6. Wound complications 7. Cost-effectiveness Wounds will be examined between 4-7 days until closure of wound. Followed up within 6 months once wound healing achieved. | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Rickard
Outcome results
None listed