Status:
WITHDRAWN
Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
Ji-Xin Cheng Laboratory
Conditions:
Diabetic Foot
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The key purpose of this study is to determine and understand the safety and effectiveness of blue light phototherapy in the treatment and healing of infected diabetic wounds, as well as determining if...
Eligibility Criteria
Inclusion
- English Speaking
- Capacity to Consent
- Diabetic Foot Ulcers
- Have an infected wound present on the foot greater than 1 (one) cm2 and less than 8 cm2
- Ability to utilize appropriate offloading devices as recommended by a clinician
Exclusion
- Pregnant or breastfeeding/nursing
- Ankle-brachial pressure index below 0.45 or over 1.4
- Hemoglobin A1c levels above 12.0
- Stage 4 renal disease/dialysis
- Taking immunosuppressant medications
- Undergoing radiation therapy
- Diagnosed Uncontrolled/Resistant hypertension (HTN) - High blood pressure that does not respond well to medical treatment, blood pressure remains above average (usually 130/80 mmHg) despite medication usage.
- Diagnosed Uncontrolled malabsorption disorder - Small intestine unable to absorb nutrients effectively, usage of nutrient supplements ineffective
- Active sepsis
- Uncontrolled coagulopathy - Blood unable to properly coagulate and form clots, low platelet or clotting factor levels, unresponsive to medications
- Untreated bone/soft tissue infection - Not yet initially treated to reduce risk of sepsis
- Gangrene of wound under care
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04285710
Start Date
June 1 2021
End Date
April 1 2022
Last Update
May 26 2021
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118