Are diabetic foot ulcers more likely to heal and heal faster when treated with RAPID biodynamic haematogel in addition to usual customary care?
- Conditions
- Diabetic foot ulcersSkin and Connective Tissue Diseases
- Registration Number
- ISRCTN55474813
- Lead Sponsor
- Biotherapy Services Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 66
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
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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
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 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% (86 mmol/mol)
4. Hb <10.5 g/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. Septicaemia
11. Platelet count of <100 x 10(9)/l
12. Serum albumin of <2.5 g/dl
13. Pregnancy
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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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method