Baylor College of Medicine

Novel Offloading to Manage Diabetic Foot Ulcers (H-37713)



Novel Offloading for Diabetic Foot Ulcers with PulseFlow Prospective Study

Principal Investigator: Bijan Najafi, Ph.D.

Reducing weight-bearing stress to diabetic foot ulcers is critical to healing and commonly called offloading boot. The traditional offloading boots often are heavy and may alter balance, which could pose a serious risk of fall related injuries. Additionally, it is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency, which is not addressed by traditional offloading.

We aim to examine the effectiveness of a novel offloading boot named PulseFlow (The Diabetic Boot Company, Ltd. UK), which uses enhanced biomechanics to reduce alteration in balance. The boot has also a mobile air bladder pump, which may address the problem associated with edema. Diabetic patients with foot ulcers are recruited for this study and will be followed for four weeks. Eligible subjects will be assessed at baseline, 48h, at one week and four weeks. Each participant will be compensated $20 per visit.

Inclusion Criteria: Male or female – 18-80 years old; Type II Diabetes with active plantar ulcer.

Exclusion Criteria: Non-ambulatory or unable to stand without help or walk a distance of at least six feet without assistance; Plantar ulcer on arch of the foot, patients with PAD (ABI< 0.5), acute foot fracture, heart failure, pregnant women, patients of immunosuppressive drugs, participation in an interventional study in the last 30 days, non-ambulatory, major amputation; patients unable or unwilling to participate in all procedures and follow-up evaluations.

For more information, please contact the research coordinators listed below.


Ivan Marin
Research Coordinator
(713) 798-7538

Ana Enriquez
Research Coordinator
(713) 798-7537

IRB: H-37713




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