Is NCT06598241 recruiting in San Antonio, TX?

Yes, NCT06598241 is currently recruiting participants at its San Antonio, TX location. This diabetic foot ulcer clinical trial is actively enrolling qualified participants.

How do I join the diabetic foot ulcer clinical trial in San Antonio?

To join this clinical trial in San Antonio, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this San Antonio clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diabetic Foot Ulcer Clinical Trial in San Antonio, TX

About This Diabetic Foot Ulcer Study in San Antonio

This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.

Sponsor: The University of Texas Health Science Center at San Antonio

Who Can Participate

Inclusion Criteria

The subject has signed the informed consent form

Subject is male or female aged between ≥ 18 or ≤ 80

Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer

Index ulcer has not received an application of BBFGM previously

Subjects with insurance coverage for BBGFM

Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.

The subject is under the care of Physician for the management of Diabetes Mellitus

Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot

Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2

Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM

The BBGFM will be applied in an outpatient setting

Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator

Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit

Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit Wagner Grade 3 subjects must have osteomyelitis diagnosed by: X-ray: suggestive or positive for changes consistent with chronic osteomyelitis or Positive probe to bone (PTB) test or Strong clinical suspicion, in the opinion of the Investigator, in the presence of osteomyelitis in the index wound

Subject does not require a surgical debridement in the operating room

Subjects without active cellulitis at the index ulcer

Subject or responsible caregiver is willing to comply with the dressing treatment and study visits

Subject is willing to utilize the offloading device to offload wound

If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.

Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment: A.Ankle-Brachial Index (ABI) of study leg(s) of ≥0.7 to ≤1.3 in conjunction with doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Or B.Toe brachial Index (TBI) of ≥ 0.50 OR C.Great Toe Pressure 50mmHg OR D.Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) of ≥40mmHg on the dorsum of the affected foot OR E.Palpable pulses

Exclusion Criteria

Subject is unwilling to sign informed consent

Subjects who cannot obtain insurance coverage for BBFGM

The BBFGM cannot be applied in an outpatient setting

Index ulcer has previously received an application of BBFGM

Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation

Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application

Subject is pregnant or breast-feeding.

Subject index ulcer associated with carcinoma.

Subject has active Charcot Neuroarthropathy

Subject requires extensive soft tissue and bone debridement in the operating room

Subject has a life expectancy of less than six months as assessed by the investigator.

Subject not in reasonable metabolic control in the judgment of the investigator

Subject with a known history of poor compliance with medical treatments

Subject currently undergoing cancer treatment

Subject has been on oral steroid use of \<7.5 mg daily for greater than seven consecutive days in 30 days before screening

Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening

The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening

Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.

Subject currently receiving radiation therapy or chemotherapy.

Patient currently on dialysis or planning to start dialysis.

Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator

Subject is unable to sustain off-loading as defined by the protocol

Subject index ulcer that cannot be offload by an offloading device

Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and/or presence of acute cellulitis at the index ulcer

Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study

Subjects who are permanently non-ambulatory (i.e. wheelchair bound)

The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)

Subject has an allergy to primary or secondary dressing materials used in this trial

In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Antonio?

Yes, this clinical trial (NCT06598241) has an active research site in San Antonio, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diabetic Foot Ulcer Treatment Options in San Antonio, TX

If you're searching for diabetic foot ulcer treatment options in San Antonio, TX, this clinical trial (NCT06598241) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Antonio research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diabetic foot ulcer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diabetic foot ulcer clinical trials near you to find additional studies recruiting in your area.

Diabetic Foot Ulcer Clinical Trial in San Antonio, TX

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