Status:
COMPLETED
Test of the Safety, Effectiveness, & Acceptability of An Improvised Dressing for Sickle Cell Leg Ulcers in the Tropics
Lead Sponsor:
Benskin, Linda, PhD, RN, SRN (Ghana), CWCN, CWS, DAPWCA
Collaborating Sponsors:
Wound Healing Foundation
University Hospital of the West Indies
Conditions:
Sickle Cell Leg Ulcer
Eligibility:
All Genders
13-70 years
Phase:
NA
Brief Summary
One in 300 Jamaicans have HbSS sickle cell disease, and of these, up to 70% will suffer from sickle cell leg ulcers (SCLUs). Of these, 24% will have a chronic SCLU (one lasting longer than 6 months). ...
Detailed Description
This study's primary purpose is to determine if an improvised dressing, made from inexpensive materials available for purchase in rural as well as urban settings, is a safe and effective, culturally a...
Eligibility Criteria
Inclusion
- Diagnosed with HbSS or HbSβ0 sickle cell disease
- Ages 13 - 70 years at study initiation (able to comprehend and give consent)
- Males and females, pregnancy is not an issue
- Open wound below the knee, not including the plantar surface of the foot
- Wound open for longer than one month (defined as a chronic SCLU)
- Traumatic, spontaneous, or recurrent SCLU (all etiologies)
Exclusion
- Patient younger than 13 years of age at study initiation
- Patient older than 70 years of age at study initiation
- Wound open for less than one month by conclusion of study enrollment period (acute wounds could be traumatic wounds unrelated to sickle cell diagnosis)
- Diagnosis of cancer, hypertension, or chronic renal failure
- Diabetes (will screen for undiagnosed diabetes)
- Active wound infection (evidenced by clinical signs of malodor, dark-colored or thick drainage, or significantly increased warmth at the periwound) which is not resolved by the conclusion of the study enrollment period
- Osteomyelitis (if osteomyelitis is suspected, an ESR will be drawn; \> 70mm/h with high platelet levels and low serum albumin warrants a bone biopsy)
- Hydroxyurea use (may be a confound because it reduces inflammation and negates much of the pathology of SSD - may choose to abstain for the study)
Key Trial Info
Start Date :
July 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04479618
Start Date
July 6 2021
End Date
February 20 2022
Last Update
September 28 2023
Active Locations (1)
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1
University Hospital of the West Indies
Mona, Kingston, Jamaica