Fat Tissue Injection Nearly Doubles Healing After Diabetic Foot Surgery
Roberto Lonardi, Nicola Leone, Stefano Gennai, Giulia Trevisi Borsari, Tea Covic, Roberto Silingardi · Journal of Clinical Medicine · 2019
Study Tests Regenerative Approach for Amputation Wounds
Diabetic foot ulcers affect millions of people and can lead to minor amputations of toes or parts of the foot. Unfortunately, these surgical wounds often fail to heal properly. When healing fails, patients may face major limb amputation. Researchers in Italy conducted a clinical trial to see if injecting the patient's own processed fat tissue could improve healing rates after minor foot amputations.
114 Patients Randomly Assigned to Two Treatment Groups
This randomized controlled trial enrolled 114 people with diabetes who needed minor foot amputations due to irreversible ulcers or gangrene. Patients were randomly divided into two groups. One group received standard wound care after surgery. The other group received standard care plus an injection of their own micro-fragmented adipose tissue (specially processed fat tissue from their own body). The fat was collected from the abdomen or thigh during the same surgery and processed using the Lipogems® system. This technology gently breaks down fat tissue while preserving its natural healing components, including pericytes (helper cells that support blood vessel healing) and mesenchymal stem cells (regenerative cells).
Treated Patients Showed 80% Healing Versus 46% for Standard Care
After six months, the results showed a dramatic difference between the two groups. In the group receiving the fat tissue injection, 80% of amputation wounds healed completely. In the standard care group, only 46% healed. This means patients who received the regenerative treatment were nearly twice as likely to heal successfully. The difference was statistically significant, meaning it was very unlikely to occur by chance alone.
No Treatment-Related Side Effects or Wound Relapses Reported
Safety was an important consideration in this trial. Researchers found no adverse events related to the fat tissue injection. The procedure was technically successful in every case. Perhaps most encouraging, none of the successfully healed wounds in the treatment group reopened or relapsed during the six-month follow-up period. Patients in the treatment group also showed improved skin quality around their wounds. Pain levels were similar between both groups throughout the study.
Why This Matters for Diabetic Foot Patients
Failed healing after minor amputation often leads to major amputation. Major amputation dramatically affects quality of life and carries serious health risks. Studies show mortality rates of 10 to 50 percent within one year after major amputation. By improving healing rates after minor procedures, this approach could help patients avoid these devastating outcomes. The treatment uses the patient's own tissue, eliminating concerns about rejection or disease transmission from donors.
A Promising Option Worth Discussing With Your Doctor
This randomized trial provides strong evidence that micro-fragmented adipose tissue injection can significantly improve healing after diabetic foot minor amputations. The procedure adds minimal time to existing surgery since fat is harvested and processed during the same session. The Lipogems® system requires no complex laboratory processing or cell expansion. For patients facing minor foot amputation due to diabetic complications, this treatment option may offer meaningful benefits. Ask your healthcare provider whether this approach might be appropriate for your situation.
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Source: Lonardi et al., Journal of Clinical Medicine, 2019.
Original Publication
Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF)
Roberto Lonardi, Nicola Leone, Stefano Gennai, Giulia Trevisi Borsari, Tea Covic, Roberto Silingardi · Journal of Clinical Medicine · 2019
The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing 'minor' amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care. In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain. At 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p=0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The results suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU.